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U.S. Department of Health and Human Services

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Enforcement Report for October 25, 2006

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities

October 25, 2006
06-43

 

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

______________________________
PRODUCT
Nutritech Calcium Complex Powdered Dietary Supplement "ALL ONE Calcium Complex", 8.5 ounce jug, Recall # F-005-7
CODE
Lot numbers: 12420/01/07, 04529/06/07, 03526/03/07, 09421/10/06, 04431/05/06, 03409/03/06 and 07425/08/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutritech Corporation, Santa Barbara, CA, by press release and letter beginning on May 12, 2006.
Manufacturer: Northridge Laboratories Inc., Chatsworth, CA. Firm initiated recall is ongoing.
REASON
The label of the product is false and misleading, since it represented the product as "Vegan" when in fact it contained milk derivatives.
VOLUME OF PRODUCT IN COMMERCE
21,028
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Vegan Parmesan Flavor Grated Soy Topping, 4 oz. shaker canister, UPC 77172-64000, Recall # F-006-7
CODE
USE BY date codes: 04/01/07, 04/15/07, 04/29/07, 05/27/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dari Concepts, LP, Springfield, MO, by telephone and letter dated July 14, 2006 and by press release on July 15, 2006.
Manufacturer: Dairi Concepts, LP, Greenwood WI. Firm initiated recall is ongoing.
REASON
Vegan Parmesan Flavor Grated Soy Topping may contain traces of undeclared milk ingredients.
VOLUME OF PRODUCT IN COMMERCE
45,264 canisters
DISTRIBUTION
MO
 

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS II

______________________________
PRODUCT
Cookies in clear, hard shell plastic clamshell labeled Jana's SUPER CHUNKY CHOCOLATE Net Wt 12 oz , 10 cookies/pkg, 12 pkg/case UPC 89805 68883, Recall # F-001-7
CODE
06206 13L1, 06206 14L1, 06206 15L1, 06206 16L1, 06206 17L1 applied by ink jet
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kerry Ingredients Intl., Beloit, WI, by telephone on August 30, 2006 and by faxed and/or e-mailed letters on September 1, 2006.
Manufacturer: Kerry Sweets Ingredients Inc., Tualatin, OR. Firm initiated recall is complete.
REASON
Product contains undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
496 cases/12 packages per case
DISTRIBUTION
CA, UT, and OR

______________________________
PRODUCT
a) Cinnamon Apple Herbal Tea, individual tea bags in sealed paper packets.
30 tea bags/6 boxes/case. Bags and boxes labeled Cinnamon Apple
Herbal Tea CAFFEINE FREE 100% Natural Ingredients CINNAMON,
HIBISCUS, ORANGE PEEL, ALLSPICE, SPICES, NATURAL APPLE AND
OTHER NATURAL FLAVORS. SYSCO.IMPERIAL, UPC code on boxes:
7486537188; Recall # F-002-7;
b) Raspberry Herbal Tea individual tea bags in sealed paper packets.
30 tea bags/6 boxes/case. Bags and boxes labeled Raspberry Herbal
Tea CAFFEINE FREE 100% Natural Ingredients HIBISCUS FLOWERS,
ROSEHIPS, ORANGE PEEL, LEMONGRASS, ROSEBUDS, LICORICE
POWDER AND NATURAL RASPBERRY FLAVORS. SYSCO.IMPERIAL.
UPC code on boxes: 07486537200, Recall # F-003-7;
c) ASSORTED TEA 10 FLAVOR REFILL & ASSORTED TEA 10 FLAVOR
WITH RACK - case contains 10 different boxes, each box containing 30
packets of one specific flavor of tea. Included in this assortment is a box of
Raspberry & Herbal Tea and a box of Cinnamon Apple Herbal Tea. UPC for
assorted tea refill 07486538593. UPC for assorted tea refill with rack
07486537203, Recall # F-004-7
CODE
a) 6L02811, 6L02812, 6L00721, 6L00722, 6L01621, 6L01622 embossed into boxes
b) 6L01711, 6L01712, 6L00721, 6L00722, 6L02731, 6L02732 embossed into boxes
c) 6L01011, 6L01012, 6L02711, 6L02712, 6L01521, 6L01522, 6L01621, 6L01622,
6L01431, 6L01432, 6L01531, 6L01532, 6L02331, 6L02332, 6L02831, 6L02832,
6L03031, 6L03032. Assorted Tea refills with rack: 6L01011, 6L01012, 6L01431,
6L01432, 6L02831, 6L02832
RECALLING FIRM/MANUFACTURER
Recalling Firm: Universal Tea Company, Inc., Tigard, OR, by letter on April 13, 2006.
Manufacturer: Yamamoto of Orient, Inc., Pomona, CA. Firm initiated recall is complete.
REASON
Herbal tea bags contain undeclared soy lecithin and are distributed post-FALCPA.
VOLUME OF PRODUCT IN COMMERCE
1,861 boxes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) RAW REVOLUTION ORGANIC LIVE FOOD BAR Raspberry & Chocolate,
Net Wt. 2.2 oz. (64g), Kosher, USDA ORGANIC. Each bar is individually
wrapped in a red & black colored wrapper, 12 bars per display box, 12 -- 12
packs per carton (144 bars). UPC 8 99587 00025 7; UPC 8 99587 00033 2,
Recall # F-010-7;
b) RAW REVOLUTION ORGANIC LIVE FOOD BAR Raisin and Chocolate,
Net Wt. 2.2 oz. (64g), Kosher, USDA ORGANIC --- bar is individually
wrapped in a purple & black colored wrapper, 12 bars per display box, 12 - 12
packs per carton (144 bars). UPC 8 99587 00024 0; UPC 8 99587 00032 5,
Recall # F-011-7
CODE
Bar: Lot 060907, Box: EXP060907, Master Case: BEST BY 060907;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Raw Indulgence, Ltd., Hawthorne, NY, by telephone on September 12, 2006, and by press release and letters dated September 14, 2006.
Manufacturer: Raw Indulgence, Ltd., Poughkeepsie, NY. Firm initiated recall is ongoing.
REASON
Firm received consumer complaints of finding small metal fragments in the food bars.
VOLUME OF PRODUCT IN COMMERCE
Approx. 8000 bars
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) CALCIUM CARBONATE 600 MG Tablets, 250 count bags, NDC #61392051125
& 30 count boxes, NDC #61392051130 Supplement, Recall # F-013-7;
b) CALCIUM CARBONATE 600 W/D 600MG Tablets, 250 count bags.
NDC #61392044525 & 30 count boxes NDC #61392044530 Supplement,
Recall # F-014-7;
c) CALCIUM W/D 250MG/125IU Tablets, 30 count boxes (NDC #61392004730) &
60 count boxes (NDC #61392004760) Supplement, Recall # F-015-7;
d) CALCIUM W/D 500MG/200IU Tablets, 30 count boxes (NDC #61392065330),
supplement, Recall # F-016-7;
e) CERTAGEN Tablets, 250 count bags (NDC #61392056025) &
30 count boxes (NDC #61392056030) Supplement, Recall # F-017-7;
f) FERROUS SULFATE 325MG tablets GREEN, 60 count boxes
(NDC #61392012760), Supplement, Recall # F-018-7;
g) FERROUS GLUCONATE 324mg Tablets, 250 count bags
(NDC#61392022625) & 30 count boxes (NDC #61392022630)
Supplement, Recall # F-019-7;
h) MAGNESIUM OXIDE 400MG Tablets, 30 count boxes
(NDC #61392097930) Supplement, Recall # F-020-7;
i) MULTIVITAMINS, THER W-MINERALS Tablets, 250 count bags
(NDC #61392035125) & 30 count boxes (NDC #61392035130)
Supplement, Recall # F-021-7;
j) MULTIVITAMINS, THERAPEUTIC Tablets, 250 count bags
(NDC #61392035025) & 30 count boxes (NDC #61392035030)
Supplement, Recall # F-022-7;
k) ONE TAB DAILY Tablets, 250 count bags (NDC #61392093825)
& 30 count boxes (NDC #61392093830) Supplement,
Recall # F-023-7;
l) ONE TAB DAILY W/IRON Tablets, 250 count bags (NDC #6139201525)
& 30 count boxes (NDC #6139201530) Supplement, Recall # F-024-7;
m) OYSTER SHELL 500mg Tablets, 250 count bags (NDC #61392000625)
Supplement, Recall # F-025-7;
n) VITAMIN B1 (THIAMINE) 100MG Tablets, 250 count bags
(NDC #61392002125) & 30 count boxes (NDC #61392002130)
Supplement, Recall # F-026-7;
o) VITAMIN B1 (THIAMINE) 50MG Tablets, 250 count bags
(NDC #61392050625) & 30 count boxes (NDC #61392050630)
Supplement, Recall # F-027-7;
p) VITAMIN B12 100MCG Tablets, 250 count bags (NDC #61392057525)
& 30 count boxes (NDC #61392057530) Supplement, Recall # F-028-7;
q) VITAMIN B12 500MCG Tablets, 250 count bags (NDC #61392050325)
& 30 count boxes (NDC #61392050330) Supplement, Recall # F-029-7;
r) VITAMIN B6 (PYRIDOXINE) 100MG Tablets, 250 count bags
(NDC #61392080625) & 30 count boxes (NDC #61392080630) Supplement,
Recall # F-030-7;
s) VITAMIN C 250MG Tablets (ASCORBIC ACID), 250 count bags
(NDC #61392015525) & 30 count boxes (NDC #61392015530)
Supplement, Recall # F-031-7;
t) VITAMIN C 500MG Tablets (ASCORBIC ACID), 250 count bags
(NDC #613920155625), 30 count boxes (NDC #613920155630)
and 60 count boxes NDC #613920155660) Supplement, Recall # F-032-7;
u) VITAMIN E 200IU Capsules, 250 count bags (NDC #61392050425) and 30
count boxes (NDC #61392050430) Supplement, Recall # F-033-7;
v) VITAMIN E 400IU Capsules, 250 count bags (NDC #61392002225) and 30
count boxes (NDC #613920022230) Supplement, Recall # F-034-7
CODE
a) K43303R25, and K43303R30;
b) K34640A25, K35453A25, K35978B25, K35978F25, K36370A25,
K41776A25, K36712B25, K37095A25, K37569A25, K38138A25,
K38769B25, K40096A25, K40179A25, K40704A25, K35433B30,
K35670A30, K35670B30, K35978A30, K35978C30, K35978D30,
K35978E30, K36370B30, K41776B30, K36712A30, K37083A30,
K37095B30, K3569B30, K37569C30, K38138B30, K3555A30,
K38555B30, K38769A30, K38769C30, K39419A30, K39419B30,
K40096B30, K40179B30, K40278A30, K40564A30, K40704B30 &
K41071A30;
c) K, 39012A30, K39012B30, K39330A30 and K33952A60;
d) K41957A30 and K41958A30;
e) K38903B25, K40093A25, K40093C25, K40473B25, K41423A25,
K41423C25, K42681A25, K38902A30, K38932A30, K38903C30,
K39486A30, K40093B30, K40473A30, K41423B30, K41423D30,
K41968A30, and K46281B30;
f) K42757R60;
g) K37485R25, K37794A235, K378123A25, K37485R30, K37794A30,
K39328A30, K39328B30, K37823A30, and K42403A30;
h) K40645R30, K42387R30;
i) K41984A25, K41984B30;
j) K41822A25, K36803A25, K41822B30, K38340A30, K38991A30;
k) K41044A25, K35609A30, K36127A30, K36816A30;
l) K36774A25, K4112A25, K36774B30, K42580A30, K39331A30,
K3931B30, K40430A30, K40430B30, K41122B30;
m) K34599A25;
n) K40798R25, K42199R25, K42836R25, K40316R25, K43420R25,
K40798R30, K42198R30, K42199R30, K42836R30, K40316R30,
K43420R30;
o) K41612A25, K39063R25, K39443A25, K40569A25, K40863A125,
K41612B30, K39063R30, K39443B30, K39734A30, K39734B30,
K40569B30, K40863B30;
p) K36989R25, K42145A25, K37341R25, K37714R25, K38105A25,
K38537A25, K40570A25, K41255A25, K36989R30, K42145B30,
K37341R30, K37714R30, K38105A30, K38537B30, K38537C30,
K39735A30, K39735B30, K40415A30, K40570B30, K40803A30,
K41255B30;
q) K36718A25, K36948A25, K36948B25, K37579A25, K38282B25,
K36718A30, K38094A30, K38094D30, K39931A30, K39931A30,
K39931A30, K39931B30, K40495A30, K40495C30, K41082A30;
r) K40657R25, K41102R25, K41677R25, K42220R25, K42653R25,
K42796R25, K409657R30, K41102R30, K41677R30, K92220R30,
K4653R30;
s) K35951R25, K36306R25, K36628A25, K41949A25, K37738B25,
K39721A25, K40034A25, K40034C25, K40034E25, K40364B25,
K40482B25, K40701A25, K35951R30, K36306R30, K36628A30,
K37738A30, K37738C30, K37763A30, K37763B30, K39807A30,
K40034B30, K40034D30, K40034F30, K40364A30, K40482A30,
K40701B30, K35951R60, K36306R60;
t) K41331R25, K41722R25, K40876R30, K41331R30, K41721R30,
K41829R30, K40876R60, K41331R60, K41722R80, K41829R69;
u) K40659R25, K41519R25, K42033R25, K42299R25, K40659R30,
K41519R30, K42033R30, K42299R30;
v) K40780R25, K41412425, K41824R25, K421825R25, K42296R25,
K42823R25, K43421R25, K40780R30, K41412R30, K411824R30,
K41826R30, K42296R30, K42754R30, K42823R30, K43421R30
RECALLING FIRM/MANUFACTURER
Heartland Repack Services, LLC, Toledo, OH, by fax, telephone and letter dated July 28, 2006. Firm initiated recall is ongoing.
REASON
There is a possibility of multiple product packaging mix-ups involving nutritional supplements, OTC drugs and prescription drugs which were distributed.
VOLUME OF PRODUCT IN COMMERCE
126,125 cases
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS III

______________________________
PRODUCT
a) ALBERS Yellow Corn Meal in 20 oz. cartons, 40 oz. cartons and 5 lb. bags.
Product Order UPC (CASE): 100-50000-25045-200, 100-50000-25035-300,
& 000-50000-48100-200*** Consumer UPC: 000-50000-25045-500,
000-50000-25035-600, 000-50000-25065-300, Recall # F-007-7;
b) ALBERS White Corn Meal in 20 oz. cartons and 40 oz. cartons.
Product Order UPC (CASE): 100-50000-27045-000 & 100-50000-27035-100***
Consumer UPC: 000-50000-27045-300 & 000-50000-27035-400,
Recall # F-008-7;
c) ALBERS Quick Grits in 20 oz. cartons, 40 oz. cartons and 5 lb. bags.
Product Order UPC (CASE):100-50000-29165-300, 100-50000-29155-400,
& 000-50000-47595-700 *** Consumer UPC: 000-50000-29165-600,
000-50000-29155-700, & 000-50000-29015-400, Recall # F-009-7
CODE
All products produced in 2006: All Albers products whose manufacturing code begins with the number 6 (6 = 2006 production)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle USA, Glendale, CA, by e-mail, hand delivery or fax on September 28, 2006.
Manufacturer: Archer Daniels Midland, Corp., Fremont, NB. Firm initiated recall is ongoing.
REASON
Food storage pest infestation.
VOLUME OF PRODUCT IN COMMERCE
a) 20 oz. - 23,982; 40 oz. - 37,765; 5 lbs. - 6,093
b) 20 oz. - 1,430; 40 oz. - 10,170
c) 20 oz. - 27,663; 40 oz. - 16,925; 5 lbs. - 2,097
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Real Lemon Iced Tea, Natural Lemon Flavor, packaged 16-fl. oz. glass bottles, 112 bottles/case, Recall # F-012-7
CODE
CT82327F6, CT82328F6, CT82305G6, CT82306G6, CT82307G6, CT82308G6, CT82310G6, CT82315G6, CT82318G6, CT82319G6, CT82324G6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mott, Rye Brook, NY, by telephone on August 9, 2006 and by e-mail on/about August 10, 2006.
Manufacturer: American Beverage Co of St. Louis, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
Product is spoiled due to yeast contamination.
VOLUME OF PRODUCT IN COMMERCE
92,744/12 bottle cases
DISTRIBUTION
OH, AL, PA, OK, and CA
 

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
ADVAIR DISKUS® (fluticasone propionate/salmeterol inhalation powder), 250/50 mcg, 60-dose pack, Rx only, NDC 0173-0696-00, Recall # D-006-7
CODE
Lot: 6ZP3320, exp. 08/07
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline Inc., Zebulon, NC, by letters beginning on September 19, 2006. Firm initiated recall is ongoing.
REASON
The Diskus unit may be defective resulting in medication not being dispensed as the doses are advanced.
VOLUME OF PRODUCT IN COMMERCE
22,530 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Acetaminophen 500 mg Caplet, 250 count bags (NDC 61392-948-25)
& 30 count boxes (NDC 61392-948-30), OTC, Recall # D-007-7;
b) Acetaminophen 500mg Tablets, 250 count bags (NDC 61392-030-25),
& 60 count boxes (NDC 61392-030-60), OTC, Recall # D-008-7;
c) Acetazolamide 250mg Tablet, 250 count bags (NDC 61392-176-25)
& 30 count boxes (NDC 61392-176-30), Rx, Recall # D-009-7;
d) Albuterol Sulfate 2mg Tablet, 250 count bags (NDC 61392-567-25),
30 count boxes (NDC 61392-567-30), 60 count boxes (NDC 61392-567-60),
& 90 count boxes (NDC 61392-567-90), Rx, Recall # D-010-7;
e) Albuterol Sulfate 4mg Tablet, 250 count bags (NDC 61392-570-25)
& 30 count boxes (NDC 61392-570-30), Rx, Recall # D-011-7;
f) Allopurinol 100mg Tablet, 30 count boxes (NDC 61392-103-30),
60 count boxes (NDC 61392-103-60), 90 count boxes (NDC 61392-103-90),
Rx, Recall # D-012-7;
g) Allopurinol 300mg Tablet, 250 count bags (NDC 61392-104-25),
& 30 count boxes (NDC 61392-104-30), Rx, Recall # D-013-7;
h) Altace 10mg Capsules, 250 count bags (NDC 61392-426-25), &
30 count boxes (NDC 61392-426-30), Rx, Recall # D-014-7;
i) Amantadine 100mg Capsules, 250 count bags (NDC 61392-042-25),
30 counts boxes (NDC 61392-042-30) & 60 count boxes
(NDC 61392-042-60), Rx, Recall # D-015-7;
j) Amiodarone 200mg Tablet, 250 count bags (NDC 61392-935-25),
30 count boxes (NDC 61392-935-30) & 60 count boxes
(NDC 61392-935-60), Rx, Recall # D-016-7;
k) Amitriptyline 100mg Tablet, 250 count bags (NDC 61392-153-25),
30 count boxes (NDC 61392-153-30) & 60 count boxes
(NDC 61392-153-60), Rx, Recall # D-017-7;
l) AMITRIPTYLINE 25mg TAB, 250 count bags (NDC 61392-140-25),
30 count boxes (NDC 61392-140-30) & 60 count boxes
(NDC 61392-140-60), Rx, Recall # D-018-7;
m) AMITRIPTYLINE 50mg TAB, 250 count bags (NDC 61392-141-25),
30 count boxes (NDC 61392-141-30) & 60 count boxes
(NDC 61392-141-60), Rx, Recall # D-019-7;
n) ASPIRIN 325mg TAB, 30 count boxes (NDC 61392-033-30), OTC,
Recall # D-020-7;
o) ASPIRIN BUFFERED 325mg TABLET, 250 count bags
(NDC 61392-031-25) & 30 count boxes (NDC 61392-031-30),
OTC, Recall # D-021-7;
p) ASPIRIN CHEW 81mg TABLET, 250 count bags
(NDC 61392-032-25) & 30 count boxes (NDC 61392-003-20),
OTC, Recall # D-022-7;
q) ASPIRIN EC 325mg TABLET, 250 count bags
(NDC 61392-899-25) & 30 count boxes (NDC 61392-899-30),
OTC, Recall # D-023-7;
r) ASPIRIN EC 81mg TABLET, 250 count bags
(NDC 61392-096-25) & 30 count boxes (NDC 61392-096-30),
OTC, Recall # D-024-7;
s) ATENOLOL 100mg TABLET, 250 count bags
(NDC 61392-546-25), 30 count boxes (NDC 61392-546-30),
& 60 count boxes (NDC 61392-546-60), Rx, Recall # D-025-7;
t) ATENOLOL 25mg TABLET, 30 count boxes (NDC 61392-542-30),
Rx, Recall # D-026-7;
u) ATENOLOL 50mg TABLET, 250 count bags
(NDC 61392-543-25), 30 count boxes (NDC 61392-543-30),
& 60 count boxes (NDC 61392-543-60), Rx, Recall # D-027-7;
v) AVANDIA 2mg TABLET, 250 count bags (NDC 61392-427-25)
& 30 count boxes (NDC 61392-427-30), Rx, Recall # D-028-7;
w) AZATHIOPRINE 50mg TABLET, 250 count bags
(NDC 61392-804-25) & 30 count boxes (NDC 61392-804-30),
Rx, Recall # D-029-7;
x) BACLOFEN 10mg TABLET, 250 count bags
(NDC 61392-706-25) & 30 count boxes (NDC 61392-706-30),
Rx, Recall # D-030-7;
y) BACLOFEN 20mg TABLET, 250 count bags
(NDC 61392-707-25) & 30 count boxes
(NDC 61392-707-30), Rx, Recall # D-031-7;
z) BENAZEPRIL HYDROCHLORIDE 10mg Tablet,
250 count bags (NDC 61392-779-25) & 30 count boxes
(NDC 61392-779-30), Rx only, Recall # D-032-7;
aa) BENAZEPRIL HYDROCHLORIDE 20mg TABLET,
250 count bags (NDC 61392-805-25) & 30 count boxes
(NDC 61392-805-30), Rx, Recall # D-033-7;
bb) BENZONATATE 100mg CAPSULE, 250 count bags
(NDC 61392-572-25) & 30 count boxes (NDC 61392-572-30),
Rx, Recall # D-034-7;
cc) BENZTROPINE MESYLATE 0.5mg TABLET, 250 count bags
(NDC 61392-167-25), 30 count boxes (NDC 61392-167-30),
60 count boxes (NDC 61392-167-60), & 90 count boxes
(NDC 61392-167-90), Rx, Recall # D-035-7;
dd) BENZTROPINE MESYLATE 1mg TABLET, 250 count bags
(NDC 61392-170-25), 30 count boxes (NDC 61392-170-30),
60 count boxes (NDC 61392-170-60), & 90 count boxes
(NDC 61392-170-90), Rx, Recall # D-036-7;
ee) BENZTROPINE MESYLATE 2mg TABLET, 250 count bags
(NDC 61392-164-25) & 30 count boxes (NDC 61392-164-30),
Rx, Recall # D-037-7;
ff) BETHANECHOL 10mg TABLET, 250 count bags
(NDC 61392-178-25) & 30 count boxes (NDC 61392-178-30),
Rx, Recall # D-038-7;
gg) BUMETANIDE (Lt. Green) 0.5mg TABLET, 250 count bags
(NDC 61392-048-25) & 30 count boxes (NDC 61392-048-30), Rx,
Recall # D-039-7;
hh) BUMETANIDE (Yellow) 1mg TABLET, 250 count bags
(NDC 61392-049-25) & 30 count boxes (NDC 61392-049-30),
Rx, Recall # D-040-7;
ii) BUMETANIDE (Lt. Brown) 2mg TABLET, 250 count bags
(NDC 61392-050-25) & 30 count boxes (NDC 61392-050-30),
Rx, Recall # D-041-7;
jj) BUPROPION HCl Sustained-Release 100mg TABLET,
250 count bags (NDC 61392-997-25) & 30 count boxes
(NDC 61392-997-30). Rx, Recall # D-042-7;
kk) BUPROPION HCl Sustained-Release 75mg TABLET,
250 count bags (NDC 61392-996-25) & 30 count boxes
(NDC 61392-996-30), Rx, Recall # D-043-7;
ll) BUPROPION HCl Sustatined-Release 100mg TABLET,
250 count bags (NDC 61392-520-25) & 30 count boxes
(NDC 61392-520-30), Rx, Recall # D-044-7;
mm) BUPROPION HCl Sustained-Release 150mg TABLET,
250 count bags (NDC 61392-521-25) & 30 count boxes
(NDC 61392-521-30), Rx, Recall # D-045-7;
nn) BUSPIRONE HCl 10mg TABLET, 30 count boxes
(NDC 61392-661-30) & 60 count boxes (NDC 61392-661-60),
Recall # D-046-7
oo) BUSPIRONE HCl 15mg TABLET, 250 count bags
(NDC 61392-582-25) & 30 count boxes (NDC 61392-582-30),
Rx, Recall # D-047-7;
pp) BUSPIRONE HCl 5mg TABLET, 30 count boxes
(NDC 61392-660-30) & 60 count boxes (NDC 61392-660-60),
Rx, Recall # D-048-7;
qq) BUSPIRONE HCl 7.5mg TABLET, 250 count bags
(NDC 61392-662-25), 30 count boxes (NDC 61392-662-30), &
60 count boxes (NDC 61392-662-60), Rx, Recall # D-049-7;
rr) CALCITRIOL 0.25mcg CAPSULE, 250 count bags
(NDC 61392-798-25) & 30 count boxes (NDC 61392-798-30),
Rx, Recall # D-050-7;
ss) CALCIUM CARBONATE 10GR (648mg) TABLET,
250 count bags (NDC 61392-001-25), 30 count boxes
(NDC 61392-001-30), & 60 count boxes (NDC 61392-001-60),
OTC, Recall # D-051-7;
tt) CAPTOPRIL 12.5mg TABLET, 250 count bags
(NDC 61392-604-25), 30 count boxes (NDC 61392-604-30),
60 count boxes (NDC 61392-604-60) & 90 count boxes
(NDC 61392-604-90), Rx, Recall # D-052-7;
uu) CAPTOPRIL 25mg TABLET, 250 count bags
(NDC 61392-605-25) & 30 count boxes (NDC 61392-605-30),
Rx only, Recall # D-053-7;
vv) CAPTOPRIL 50mg TABLET, 250 count bags
(NDC 61392-147-25) & 30 count boxes (NDC 61392-147-30),
Rx Only, Recall # D-054-7;
ww) CARBAMAZEPINE 200mg TABLET, 250 count bags
(NDC 61392-038-25), 30 count boxes (NDC 61392-038-30),
60 count boxes (NDC 61392-038-60) & 90 count boxes
(NDC 61392-038-90), Rx Only, Recall # D-055-7;
xx) CARBAMAZEPINE Chewable 100mg TABLET,
250 count bags (NDC 61392-029-25) & 30 count boxes
(NDC 61392-002930), Rx Only, Recall # D-056-7;
yy) CARBATROL ER (Carbamazepine) 200mg CAPSULE,
250 count bags (NDC 61392-566-25) & 30 count boxes
(NDC 61392-566-30), Rx Only, Recall # D-057-7;
zz) CARBATROL ER, (Carbamazepine), 300mg CAPSULE,
250 count bags (NDC 61392-568-25), & 30 count boxes,
(NDC 61392-568-30), Rx only, Recall # D-058-7;
aaa) CARBIDOPA and LEVODOPA 10mg/100mg TABLET,
250 count bags (NDC 61392-177-25), 30 count boxes
(NDC 61392-177-30) & 60 count boxes (NDC 61392-177-60),
Rx only, Recall # D-059-7;
bbb) CARBIDOPA and LEVODOPA 25mg/100mg TABLET,
250 count bags (NDC 61392-180-25), 30 count boxes
(NDC 61392-180-30), 60 count boxes (NDC 61392-180-60)
& 90 count boxes (NDC 61392-180-0), Rx only, Recall # D-060-7;
ccc)CARBIDOPA and LEVODOPA 25mg/250mg TABLET,
250 count bags (NDC 61392-183-25) & 30 count boxes
(NDC 61392-183-30), Rx only, Recall # D-061-7;
ddd) CARBIDOPA and LEVODOPA ER 50mg/200mg TABLET,
250 count bags (NDC 61392-647-25), 30 count boxes
(NDC 61392-647-30) & 60 count boxes (NDC 61392-647-60)
Rx only, Recall # D-062-7;
eee) CHLORPROMAZINE HYDROCHLORIDE 10mg TABLET,
250 count bags (NDC 61392-880-25) & 30 count boxes
(NDC 61392-880-30), Rx only, Recall # D-063-7;
fff) CHLORPROMAZINE HYDROCHLORIDE 200mg TABLET, 250
count bags (NDC 61392-882-25) & 30 count boxes (NDC 61392-882-30),
Rx only, Recall # D-064-7;
ggg) CHLORPROMAZINE 25mg TABLET, 250 count bags
(NDC 61392-040-25), 30 count boxes (NDC 61392-040-30) &
60 count boxes (NDC 61392-040-60), Rx only, Recall # D-065-7;
hhh) CHOLINE MAGNESIUM TRISALICYLATE 500mg TABLET,
250 count bags (NDC 61392-628-25) & 30 count boxes
(NDC 61392-628-30), Rx only, Recall # D-066-7;
iii) CHOLINE MAGNESIUM TRISALICYLATE 750mg TABLET,
250 count bags (NDC 61392-181-25) & 30 count boxes
(NDC 61392-181-30), Rx only, Recall # D-067-7;
jjj) CILOSTAZOL 100mg TABLET, 250 count bags
(NDC 61392-767-25) & 30 count boxes (NDC 61392-767-30),
Rx only, Recall # D-068-7;
kkk) CILOSTAZOL 50mg TABLET, 250 count bags
(NDC 61392-769-25) & 30 count bags (NDC 61392-769-30),
Rx only, Recall # D-069-7;
lll) CIMETIDINE 400mg TABLET, 250 count bags
(NDC 61392-200-25) & 30 count boxes (NDC 61392-200-30),
Rx only, Recall # D-070-7;
mmm) CIPROFLOXACIN 500mg TABLET, 250 count bags
(NDC 61392-495-25) & 30 count boxes (NDC 61392-495-30),
Rx only, Recall # D-071-7;
nnn) CITALOPRAM HYDROBROMIDE 10mg TABLET, 250 count bags
(NDC 61392-757-25) & 30 count bags (NDC 61392-757-30),
Rx only, Recall # D-072-7;
ooo) CITALOPRAM HYDROBROMIDE 20mg TABLET, 30 count boxes
(NDC 61392-758-30) Rx only, Recall # D-073-7;
ppp) CITALOPRAM HYDROBROMIDE 40mg TABLET, 250 count bags
(NDC 61392-759-25) & 30 count boxes (NDC 61392-759-30),
Rx only, Recall # D-074-7;
qqq) CLINDAMYCIN HYDROCHLORIDE 150mg CAPSULE, 250 count bags
(NDC 61392-512-25) & 30 count boxes (NDC 61392-512-30), Rx only,
Recall # D-075-7;
rrr) CLINDAMYCIN HYDROCHLORIDE 300mg CAPSULE, 250 count bags
(NDC 61392-774-25) & 30 count boxes (NDC 61392-774-30), Rx only,
Recall # D-076-7;
sss) CLOMIPRAMINE HYDROCHLORIDE 50mg CAPSULE, 250 count bags
(NDC 61392-885-25) & 30 count boxes (NDC 61392-885-30), Rx ONLY,
Recall # D-077-7;
ttt) CLONIDINE HCL 0.1mg TABLET, 250 count bags (NDC 61392-513-25),
30 count boxes (NDC 61392-513-30), 60 count boxes (NDC 61392-513-60),
& 90 count boxes (NDC 61392-513-90), Rx only, Recall # D-078-7;
uuu) CLONIDINE HCl 0.2mg TABLET, 250 count bags (NDC 61392-516-25),
30 count boxes (NDC 61392-516-30), 60 count boxes (NDC 61392-051-660),
90 count boxes (NDC 61392-516-90), Rx only, Recall # D-079-7;
vvv) CLONIDINE HCl 0.3mg TABLET, 250 count bags (NDC 61392-519-25)
& 30 count boxes (NDC 61392-519-30), Rx only, Recall # D-080-7;
www) CLOZAPINE 100mg TABLET, 250 count bags (NDC 61392-489-25)
& 30 count boxes (NDC 61392-489-30), Rx only, Recall # D-081-7;
xxx) CLOZAPINE 25mg TABLET, 250 count bags (NDC 61392-319-25)
& 30 count boxes (NDC 61392-319-30), Rx only, Recall # D-082-7;
yyy) COLCHICINE 0.6mg TABLET, 250 count bags (NDC 61392-174-25)
& 30 count boxes (NDC 61392-174-30), Rx only, Recall # D-083-7;
zzz) COREG 25mg TABLET, 250 count bags (NDC 61392-325-25)
& 30 count boxes (NDC 61392-325-30), Rx only, Recall # D-084-7;
aaaa) CYCLOBENZAPRINE HCl 10mg TABLET, 250 count bags
(NDC 61392-098-25) & 30 count boxes (NDC 61392-098-30), Rx only,
Recall # D-085-7;
bbbb) CYPROHEPTADINE HCl 4mg TABLET, 250 count bags
(NDC 61392-209-25), 30 count boxes (NDC 61392-209-30),
60 count boxes (NDC 61392-209-60), & 90 count boxes
(NDC 61392-209-90), Rx only, Recall # D-086-7;
cccc) DANTROLENE SODIUM 25mg CAPSULE, 250 count bags
(NDC 61392-514-25) & 30 count boxes (NDC 61392-514-30),
Rx only, Recall # D-087-7;
dddd) DEPAKOTE (divalproex sodium DR) 125mg TABLET,
250 count bags (NDC 61392-783-25) & 30 count boxes
(NDC 61392-783-30), Rx only, Recall # D-088-7;
eeee) DEPAKOTE ER (divalproex sodium ) 500mg TABLET,
250 count bags (NDC 61392-416-25) & 30 count boxes
(NDC 61392-416-30), Rx only, Recall # D-089-7;
ffff) DESMOPRESSIN 0.2mg TABLET, 250 count bags
(NDC 61392-515-25) & 30 count boxes (NDC 61392-515-30),
Rx only, Recall # D-090-7;
gggg) DICLOFENAC SODIUM Delayed-Release 50mg TABLET,
250 count bags (NDC 61392-853-25) & 30 count boxes
(NDC 61392-853-30), Rx only, Recall # D-091-7;
hhhh) DICLOFENAC SODIUM Delayed-Release 75mg TABLET,
250 count bags (NDC 61392-794-25) & 30 count boxes
(NDC 61392-794-30), Rx only, Recall # D-092-7;
iiii) DICYCLOMINE HYDROCHLORIDE 10mg CAPSULE,
250 count bags (NDC 61392-182-25), 30 count boxes
(NDC 61392-182-30), & 60 count boxes (NDC 61392-182-60),
Rx only, Recall # D-093-7;
jjjj) DICYCLOMINE HYDROCHLORIDE 20mg TABLET,
250 count bags (NDC 61392-041-25), 30 count boxes
(NDC 61392-041-30), 60 count boxes (NDC 61392-041-60),
& 90 count boxes (NDC 61392-041-90), Rx only, Recall # D-094-7;
kkkk) DIGITEK 0.125mg TABLET, 30 count boxes (NDC 61392-998-30),
Rx only, Recall # D-095-7;
llll) DIGITEK 0.25mg TABLET, 250 count bags (NDC 61392-839-25)
& 30 count boxes (NDC 61392-839-30), Rx only, Recall # D-096-7;
mmmm) DILANTIN (extended phenytoin Na) 100mg CAPSULE,
250 count bags (NDC 61392-088-25) & 30 count boxes
(NDC 61392-088-30), Rx only, Recall # D-097-7;
nnnn) DILANTIN 50mg INFATABS, (Phenytoin Tablets USP),
250 count bags (NDC 61392-712-25), 30 count boxes
(NDC 61392-712-30), & 60 count boxes (NDC 61392-712-60),
Rx only, Recall # D-098-7;
oooo) DILTIAZEM 120mg TABLET, 250 count bags (NDC 61392-145-25),
30 count boxes (NDC 61392-145-30) & 60 count boxes
(NDC 61392-145-60), Rx only, Recall # D-099-7;
pppp) DILTIAZEM 30mg TABLET, 250 count bags (NDC 61392-053-25),
30 count boxes (NDC 61392-053-30), & 60 count boxes
(NDC 61392-053-60), Rx only, Recall # D-100-7;
qqqq) DILTIAZEM 60mg TABLET, 250 count bags (NDC 61392-720-25),
30 count boxes (NDC 61392-720-30), & 60 count boxes
(NDC 61392-720-60), Rx only, Recall # D-101-7;
rrrr) DILTIAZEM 90mg TABLET, 250 count bags (NDC 61392-146-25),
30 count boxes (NDC 61392-146-30), & 60 count boxes
(NDC 61392-146-60), Rx only, Recall # D-102-7;
ssss) DILTIAZEM CD (Diltiazem HCl E.R.) 120mg CAPSULE, 30 count boxes
(NDC 61392-961-30), Rx only, Recall # D-103-7;
tttt) DILTIAZEM CD (Diltiazem HCl E.R.) 180mg CAPSULE, 250 count bags
(NDC 613920-622-5) & 30 count boxes (NDC 61392-962-30), Rx only,
Recall # D-104-7;
uuuu) DILTIAZEM CD (Diltiazem HCl E.R.) 240mg CAPSULE, 30 count
boxes (NDC 61392-963-30), Rx only, Recall # D-105-7;
vvvv) DILTIAZEM CD (Diltiazem Hcl E.R.) 300mg CAPSULE, 250 count
bags (NDC 61392-964-25) & 30 count bags (NDC 61392-964-30),
Rx only, Recall # D-106-7;
wwww: DIPHENHYDRAMINE HYDROCHLORIDE 25mg CAPSULE,
250 count bags (NDC 61392-220-25), 30 count boxes
(NDC 61392-220-30), & 60 count boxes (NDC 61392-220-60),
Rx only, Recall # D-107-7;
xxxx) DIPYRIDAMOLE 25mg TABLET, 250 count bags
(NDC 61392-549-25) & 30 count boxes (NDC 61392-549-30),
Rx only, Recall # D-108-7;
yyyy) DIPYRIDAMOLE 50mg TABLET, 250 count bags (NDC 61392-552-25),
30 count boxes (NDC 61392-552-30), 60 count boxes (NDC 61392-552-60)
& 90 count boxes (NDC 61392-552-90), Rx only, Recall # D-109-7;
zzzz) DIPYRIDAMOLE 75mg TABLET, 250 count bags (NDC 61392-142-25),
30 count boxes (NDC 61392-142-30), & 60 count boxes (NDC 61392-142-60),
Rx only, Recall # D-110-7;
aaaaa)DOCUSATE CALCIUM 240mg CAPSULE, 250 count bags
(NDC 61392-213-25) & 30 count boxes (NDC 61392-213-30),
Recall # D-111-7;
bbbbb) DOCUSATE SODIUM 250mg CAPSULE, 250 count bags
(NDC 61392-110-25) & 30 count boxes (NDC 61392-110-30),
Recall # D-112-7;
ccccc)DOXAZOSIN MESYLATE 1mg TABLET, 250 count bags
(NDC 61392-654-25), & 30 count boxes (NDC 61392-654-30),
Rx only, Recall # D-113-7;
ddddd) DOXAZOSIN MESYLATE 2mg TABLET, 250 count bags
(NDC 61392-656-25) & 30 count boxes (NDC 61392-656-30), Rx only,
Recall # D-114-7;
eeeee) DOXAZOSIN MESYLATE 4mg TABLET, 250 count bags
(NDC 61392-655-25) & 30 count boxes (NDC 61392-655-30), Rx only,
Recall # D-115-7;
fffff) DOXAZOSIN MESYLATE 8mg TABLET, 250 count bags
(NDC 61392-657-25), & 30 count boxes (NDC 61392-657-30), Rx ONLY,
Recall # D-116-7;
ggggg) DOXEPIN HYDROCHLORIDE 50mg CAPSULE, 250 count bags
(NDC 61392-122-25) & 30 count boxes (NDC 61392-122-30) Rx only,
Recall # D-117-7;
hhhhh) DOXEPIN HYDROCHLORIDE 10mg CAPSULE, 250 count bags
(NDC 61392-120-25) & 30 count boxes (NDC 61392-120-30), Rx only,
Recall # D-118-7;
iiiii)DOXEPIN HYDROCHLORIDE 25mg CAPSULE, 250 count bags
(NDC 61392-121-25) & 30 count boxes (NDC 61392-121-30), Rx only,
Recall # D-119-7;
jjjjj) DOXYCYCLINE HYCLATE 100mg TABLET, 250 count bags
(NDC 61392-517-25) & 30 count boxes (NDC 61392-517-30), Rx only,
Recall # D-120-7;
kkkkk) EFFEXOR (venlafaxine HCl) 75mg TABLET, 250 count bags
(NDC 61392-330-25), & 30 count boxes (NDC 61392-330-30), Rx only,
Recall # D-121-7;
lllll) ENALAPRIL MALEATE 10mg TABLET, 250 count bags
(NDC 61392-651-25) & 30 count boxes (NDC 61392-651-30), Rx only,
Recall # D-122-7;
mmmmm) ENALAPRIL MALEATE 2.5mg TABLET, 250 count bags
(NDC 61392-649-25) & 30 count boxes (NDC 61392-649-30), Rx only,
Recall # D-123-7;
nnnnn) ENALAPRIL MALEATE 20mg TABLET, 250 count bags
(NDC 61392-652-25) & 30 count boxes (NDC 61392-652-30), Rx only,
Recall # D-124-7;
ooooo) ENALAPRIL MALEATE 5mg TABLET, 250 count bags
(NDC #61392065025) & 30 count boxes (NDC #61392065030), Rx only,
Recall # D-125-7;
ppppp) EXELON 6mg TABLET, 250 count bags (NDC 61392-327-25)
& 30 count boxes (NDC 61392-327-30), Rx only, Recall # D-126-7;
qqqqq) FAMOTIDINE (Beige) 20mg TABLET, 250 count bags
(NDC 61392-663-25), 30 count boxes (NDC 61392-663-30) &
60 count boxes (NDC 61392-663-60), Rx only, Recall # D-127-7;
rrrrr) FAMOTIDINE (Tan) 40mg TABLET, 250 count bags
(NDC 61392-664-25) & 30 count boxes (NDC 61392-664-30), Rx only,
Recall # D-128-7;
sssss) FELODIPINE ER 10mg TABLET, 250 count bags
(NDC 61392-778-25) & 30 count boxes (NDC 61392-778-30), Rx only,
Recall # D-129-7;
ttttt) FELODIPINE ER 5mg TABLET, 250 count bags (NDC 61392-777-25) &
30 count boxes (NDC 61392-777-30), Rx only, Recall # D-130-7;
uuuuu) FEXOFENADINE HYDROCHLORIDE 180mg TABLET, 250
count bags (NDC 61392-332-25) & 30 count boxes (NDC 61392-332-30),
Rx only, Recall # D-131-7;
vvvvv) FEXOFENADINE HYDROCHLORIDE 60mg TABLET, 250 count
bags (NDC 61392-331-25) & 30 count boxes (NDC 61392-331-30),
Rx only, Recall # D-132-7;
wwwww) FLUDROCORTISONE 0.1mg TABLET, 250 count bags
(NDC 61392-583-25) & 30 count boxes (NDC 61392-583-30),
Rx only, Recall # D-133-7;
xxxxx) FLUOXETINE 10mg CAPSULE, 250 count bags (NDC 61392-668-25)
& 30 count boxes (NDC 61392-668-30), Rx only, Recall # D-134-7;
yyyyy) FLUOXETINE 10mg TABLET, 250 count bags (NDC 61392-561-25)
& 30 count boxes (NDC 61392-561-30), Rx only, Recall # D-135-7;
zzzzz) FLUOXETINE 20mg CAPSULE, 250 count bags (NDC 61392-669-25)
& 30 count boxes (NDC 61392-669-30), Rx only, Recall # D-136-7;
aaaaaa) FLUOXETINE 20mg TABLET, 250 count bags (NDC 61392-673-25),
30 count boxes (NDC 61392-673-30), & 60 count boxes (NDC 61392-673-60),
Rx only, Recall # D-137-7;
bbbbbb) FLUPHENAZINE HYDROCHLORIDE 10mg TABLET, 250 count bags
(NDC 61392-150-25), 30 count boxes (NDC 61392-150-30) & 60 count boxes
(NDC 61392-150-60), Rx only, Recall # D-138-7;
cccccc) FLUPHENAZINE HYDROCHLORIDE 1mg TABLET, 250 count bags
(NDC 61392-057-25), 30 count boxes (NDC 61392-057-30), & 60 count boxes
(NDC 61392-057-60), Rx only, Recall # D-139-7;
dddddd) FLUPHENAZINE HYDROCHLORIDE 5mg TABLET, 250 count
bags (NDC 61392-151-25), 30 count boxes (NDC 61392-151-30), 60
count boxes (NDC 61392-151-60), 90 count boxes (NDC 61392-151-90),
Rx only, Recall # D-140-7;
eeeeee) FLUVOXAMINE MALEATE 100mg TABLET, 250 count bags
(NDC 61392-667-25) & 30 count boxes (NDC 61392-667-30), Rx only,
ffffff) FLUVOXAMINE MALEATE 25mg TABLET, 250 count bags
(NDC 61392-665-25) & 30 count boxes (NDC 61392-665-30), Rx only,
Recall # D-142-7;
gggggg) FLUVOXAMINE MALEATE 50mg TABLET, 250 count bags
(NDC 61392-666-25) & 30 count boxes (NDC 61392-666-30), Rx only,
Recall # D-143-7;
hhhhhh) FOLBIC (Folacin 2.5mg, Vitamin B6 25mg, Vitamin B12 2mg)
TABLET, 250 count bags (NDC 61392-522-25) & 30 count boxes
(NDC 61392-522-30), Rx only, Recall # D-144-7;
iiiiii) FOLIC ACID 1mg TABLET, 30 count boxes (NDC 61392-244-30),
Rx only, Recall # D-145-7;
jjjjjj) FOSINOPRIL SODIUM 10mg TABLET, 250 count bags
(NDC 61392-875-25) & 30 count boxes (NDC 61392-875-30), Rx only,
Recall # D-146-7;
kkkkkk) FUROSEMIDE (White) 20mg TABLET, 60 count boxes
(NDC 61392-256-60) & 90 count boxes (NDC 61392-256-90), Rx only,
Recall # D-147-7;
llllll) FUROSEMIDE (White) 40mg TABLET, 30 count boxes (NDC 61392-253-30)
& 60 count boxes (NDC 61392-253-60), Rx only, Recall # D-148-7;
mmmmmm) FUROSEMIDE 80mg TABLET, 250 count bags (NDC 61392-254-25)
& 60 count boxes (NDC 61392-254-60), Rx only, Recall # D-149-7;
nnnnnn) GABAPENTIN 100mg CAPSULE, 250 count bags (NDC 61392-760-25)
& 30 count boxes (NDC 61392-760-30), Rx only, Recall # D-150-7;
oooooo) GABAPENTIN 100mg TABLET, 30 count boxes (NDC 61392-753-30)
& 60 count boxes (NDC 61392-753-60), Rx only, Recall # D-151-7;
pppppp) GABAPENTIN 300mg CAPSULE, 250 count bags (NDC 61392-761-25)
& 30 count boxes (NDC 61392-761-30), Rx only, Recall # D-152-7;
qqqqqq) GABAPENTIN 300mg TABLET, 250 count bags (NDC 61392-748-25),
30 count boxes (NDC 61392-074-30) & 60 count boxes (NDC 61392-748-60),
Rx only, Recall # D-153-7;
rrrrrr) GABAPENTIN 400mg CAPSULE, 250 count bags (NDC 61392-762-25)
& 30 count boxes (NDC 61392-762-30), Rx only, Recall # D-154-7;
ssssss) GABAPENTIN 400mg TABLET, 250 count bags (NDC 61392-750-25),
30 count boxes (NDC 61392-750-30), & 60 count boxes (NDC 61392-750-60),
Rx only, Recall # D-155-7;
tttttt) GABAPENTIN 600mg TABLET, 250 count bags (NDC 61392-873-25) &
30 count boxes (NDC 61392-873-30), Rx ONLY, Recall # D-156-7;
uuuuuu) GABAPENTIN 800mg TABLET, 250 count bags (NDC 61392-874-25)
& 30 count boxes (NDC 61392-874-30), Rx only, Recall # D-157-7;
vvvvvv) GABITRIL 4mg TABLET, 250 count bags (NDC 61392-491-25) &
30 count boxes (NDC 61392-491-30), Rx only, Recall # D-158-7;
wwwwww) GEMFIBROZIL 600mg TABLET, 250 count bags (NDC 61392-093-25),
30 count boxes (NDC 613920-093-30) & 60 count boxes (NDC 61392-093-60),
Rx only, Recall # D-159-7;
xxxxxx) GLIMEPIRIDE 4mg TABLET, 250 count bags (NDC 61392-594-25) &
30 count boxes (NDC 61392-594-30), Rx only, Recall # D-160-7;
yyyyyy) GLIMEPRIRIDE 1mg TABLET, 250 count bags (NDC 61392-596-25) &
30 count boxes (NDC 61392-596-30), Rx only, Recall # D-161-7;
zzzzz) GLIMEPRIRIDE 2mg TABLET, 250 count bags (NDC 61392-595-25) &
30 count boxes (NDC 61392-595-30), Rx only, Recall # D-162-7;
aaaaaaa) GLIPIZIDE 10mg TABLET, 250 count bags (NDC 61392-064-25),
30 count boxes (NDC 61392-064-30), & 60 count boxes (NDC 61392-064-60),
Rx only, Recall # D-163-7;
bbbbbbb) GLIPIZIDE 5mg TABLET, 250 count bags (NDC 61392-063-25),
30 count bags (NDC 61392-063-30), & 60 count bags (NDC 61392-063-60),
Rx only, Recall # D-164-7;
ccccccc) GLIPIZIDE ER 2.5mg TABLET, 250 count bags (NDC 61392-766-25)
& 30 count boxes (NDC 61392-766-30), Rx only, Recall # D-165-7;
ddddddd) GLUCOSAMINE SULFATE 500mg CAPSULE, 250 count bags
(NDC 61392-635-25) & 30 count boxes (NDC 61392-635-30), Rx only,
Recall # D-166-7;
eeeeeee) GLYBURIDE 1.25mg TABLET, 250 count bags (NDC 61392-724-25)
& 30 count boxes (NDC 61392-724-30), Rx only, Recall # D-167-7;
fffffff) GLYBURIDE 2.5mg TABLET, 250 count bags (NDC 61392-709-25) &
30 count boxes (NDC 61392-709-30), Rx only, Recall # D-168-7;
ggggggg) GLYBURIDE 5mg TABLET, 250 count bags (NDC 61392-834-25),
Rx only, Recall # D-169-7;
hhhhhhh) GLYBURIDE and METFORMIN HCL 2.5mg/500mg TABLET,
250 count bags (NDC 61392-592-25) & 30 count boxes (NDC 61392-592-30),
Rx only, Recall # D-170-7;
iiiiiii) GLYBURIDE and METFORMIN 5mg/500mg TABLET, 250 count bags
(NDC 61392-593-25) & 30 count boxes (NDC 61392-593-30), Rx only,
Recall # D-171-7;
jjjjjjj) GLYCOPYRROLATE 1mg TABLET, 250 count bags (NDC 61392-523-25)
& 30 count boxes (NDC 61392-523-30), Rx only, Recall # Z-172-7;
kkkkkkk) GUAIFENEX DM 600mg/30mg TABLET, 250 count bags
(NDC 61392-524-25) & 30 count boxes (NDC 61392-524-30), Rx only,
Recall # D-173-7;
lllllll) HALOPERIDOL 0.5mg TABLET, 250 count bags (NDC 61392-263-25),
30 count boxes (NDC 61392-263-30), 60 count boxes (NDC 61392-263-60)
& 90 count boxes (NDC 61392-263-90), Rx only, Recall # D-174-7;
mmmmmmm) HALOPERIDOL 10mg TABLET, 250 count bags (NDC 61392-275-25),
30 count boxes (NDC 61392-275-30), & 60 count boxes (NDC 61392-275-60),
Rx only, Recall # D-175-7;
nnnnnnn) HALOPERIDOL 1mg TABLET, 250 count bags (NDC 61392-266-25)
& 30 count boxes (NDC 61392-266-30), Rx only, Recall # D-176-7;
ooooooo) HALOPERIDOL 2mg TABLET, 250 count bags (NDC 61392-269-25),
30 count boxes (NDC 61392-269-30), 60 count boxes (NDC 61392-269-60)
& 90 count boxes (NDC 61392-269-90), Rx only, Recall # D-177-7;
ppppppp) HALOPERIDOL 5mg TABLET, 250 count bags (NDC 61392-272-25),
30 count boxes (NDC 61392-272-30) & 60 count boxes (NDC 61392-272-60)
Rx only, Recall # D-178-7;
qqqqqqq) HYDRALAZINE HYDROCHLORIDE 100mg TABLET, 250 count bags
(NDC 61392-498-25) 30 count boxes (NDC 61392-498-30), Rx only,
Recall # D-179-7;
rrrrrrr) HYDRALAZINE HYDROCHLORIDE 25mg TABLET, 250 count bags
(NDC 61392-043-25), 60 count boxes (NDC 61392-043-60), Rx only,
Recall # D-180-7;
sssssss) HYDRALAZINE HYDROCHLORIDE 50mg TABLET, 250 count bags
(NDC 61392-637-25) & 30 count boxes (NDC 61392-637-30), Rx only,
Recall #-D-181-7;
ttttttt) HYDROCHLOROTHIAZIDE 12.5mg CAPSULE, 250 count bags
(NDC 61392-577-25), 30 count boxes (NDC 61392-577-30) & 60 count
boxes (NDC 61392-577-60), Rx only, Recall # D-182-7;
uuuuuuu) HYDROCHLOROTHIAZIDE 25mg TABLET, 250 count bags
(NDC 61392-011-25), 30 count boxes (NDC 61392-011-30), 60 count
boxes (NDC 61392-011-60) & 90 count boxes (NDC 61392-011090),
Rx only, Recall # D-183-7;
vvvvvvv) HYDROXYZINE HCl 10mg TABLET, 250 count bags
(NDC 61392-012-25) & 30 count boxes (NDC 61392-012-30), Rx only,
Recall # D-184-7;
wwwwwww) HYDROXYZINE HCl 25mg TABLET, 250 count bags
(NDC 61392-013-25) & 30 count bags (NDC 61392-013-30), Rx only,
Recall # D-185-7;
xxxxxxx) HYDROXYZINE PAMOATE 25mg CAPSULE, 250 count bags
(NDC 61392-801-25) & 30 count boxes (NDC 61392-801-30), Rx only,
Recall # D-186-7;
yyyyyyy) IBUPROFEN 400mg TABLET, 250 count bags
(NDC 61392-527-25) & 30 count boxes (NDC 61392-527-30), Rx only,
Recall # D-187-7;
zzzzzzz) IBUPROFEN 600mg TABLET, 250 count bags
(NDC 61392-529-25), 30 count boxes (NDC 61392-529-30), &
60 count boxes (NDC 61392-529-60), Rx only, Recall # D-188-7;
aaaaaaaa) IBUPROFEN 800mg TABLET, 250 count bags
(NDC 61392-528-25) & 30 count boxes (NDC 61392-528-30), Rx only,
Recall # D-189-7;
bbbbbbbb) IMIPRAMINE HYDROCHLORIDE 10mg TABLET,
250 count boxes (NDC #61392002525) & 30 count boxes
(NDC #61392002530), Rx only, Recall # D-190-7;
cccccccc) IMIPRAMINE HYDROCHLORIDE 25mg TABLET,
250 count bags (NDC 61392-026-25), 30 count boxes
(NDC 61392-026-30), 60 count boxes (NDC 61392-026-60)
& 90 count boxes (NDC 61392-026-90, Rx only, Recall # D-191-7;
dddddddd) IMIPRAMINE HYDROCHLORIDE 50mg TABLET,
30 count boxes (NDC 61392-027-30), Rx only, Recall # D-192-7;
eeeeeeee) INDAPAMIDE 2.5mg TABLET, 250 count bags
(NDC 61392-537-25) & 30 count boxes (NDC 61392-537-30),
Rx only, Recall # D-193-7;
ffffffff) INDOMETHACIN 25mg CAPSULE, 250 count bags
(NDC 61392-815-25) & 30 count boxes (NDC 61392-815-30),
Rx only, Recall # D-194-7;
gggggggg) INDOMETHACIN 50mg CAPSULE, 250 count bags
(NDC 61392-841-25) & 30 count boxes (NDC 61392-841-30),
Rx only, Recall # D-195-7;
hhhhhhhh) ISONIAZID 300mg TABLET, 250 count bags
(NDC 61392-803-25) & 30 count boxes (NDC 61392-803-30),
Rx only, Recall # D-196-7;
iiiiiiii) ISOSORBIDE DINITRATE 10mg TABLET, 30 count boxes
(NDC 61392-305-30) & 90 count boxes (NDC 61392-305-90),
Rx only, Recall # D-197-7;
jjjjjjjj) ISOSORBIDE DINITRATE 20mg TABLET, 250 count bags
(NDC 61392-321-25), 30 count boxes (NDC 61392-321-30),
60 count boxes (NDC 61392-321-60) & 90 count boxes
(NDC 61392-321-90), Rx only, Recall # D-198-7;
kkkkkkkk) ISOSORBIDE DINITRATE 30mg TABLET, 250 count
bags (NDC 61392-318-25), 30 count boxes (NDC 61392-318-30),
60 count boxes (NDC 61392-318-60), & 90 count boxes
(NDC 61392-318-90), Rx only, Recall # D-199-7;
llllllll) ISOSORBIDE DINITRATE 5mg TABLET, 250 count bags
(NDC 61392-311-25), 30 count boxes (NDC 61392-311-30),
60 count boxes (NDC 61392-311-60) & 90 count boxes
(NDC 61392-311-90), Rx only, Recall # D-200-7
CODE
a) K33941A25, K33941A30, K39905A30, K41308R30;
b) K41896R25, K41896R30, K35231A60, K38523A60;
c) K36446R25, K36742A25, K42076A25, K42544B25, K37393A25,
K37764A25, K39990A25, K36446R30, K36742A30, K42544A30,
K37238A30, K37764B30, K38281A30, K38281B30, K38281C30,
K39353A30, K40485A30, K40865A30;
d) K34508B25, K35367A25, K36367A25, K36367B25, K36367F25,
K41574A25, K38079B25, K34508A30, K35367D30, K36367C30,
K36367D30, K36367E30, K41574B30, K38079A30, K38798A30,
K35367B60, K35367C60, K34508C90;
e) K35371A25, K35371B25, K42138A25, K37464A25, K38863A25,
K40864A25, K35371C30, K35371D30, K37759A30, K37759B30,
K38863B30, K39418A30, K40864B30;
f) K41541A30, K36714A30, K36714B30, K37239A30, K38182A30,
K39242A30, K35251A60, K35251B90;
g) K35233A25, K36369B25, K36369C25, K36707A25, K42481A25,
K38309A25, K40188A25, K40708A25, K36369A30, K36369D30,
K41579A30, K36707B30, K36707C30, K42481B30, K37743A30,
K38057A30, K38309B30, K40188B30, K40708B30, K40915A30,
K40980A30;
h) K42619R25, K42953R25, K42619R30, K42953R30;
i) K34254A25, K35345A25, K35345B25, K37042A25, K37042B25,
K39351B25, K34254A30, K34520B30, K42335A30, K39351A30,
K39351C30, K33845A60, K34520A60, K35247A60;
j) K37113C25, K38748A30, K41004A30, K37112A60,
K37113A60, K37113B60;
k) K34130R25, K35235A25, K41733A25, K38770B25, K40519A25,
K34130R30, K42418A30, K43197A30, K37688A30, K37688B30,
K38770A30, K38770C30, K39733A30, K40118A30, K40519B30,
K40862A30, K34130R60;
l) K34214B25, K34214C25, K35981B25, K35981F25, K35981G25,
K35981H25, K36360C25, K36798A25, K36798C25, K42073A25,
K38058A25, K40760A25, K34214A30, K34214D30, K35981A30,
K35981D30, K36360A30, K36360B30, K36798B30, K42073B30,
K37742A30, K38058B30, K38308A30, K38767A30, K38767B30,
K39243A30, K39244A30, K40760B30, K40866A30, K41144A30,
K35981C60, K35981E60;
m) K34942A25, K34942B25, K34942D25, K35980A25, K35980D25,
K35980E25, K35980F25, K41457A25, K42762A25, K38698A25,
K39998A25, K35980B30, K35980G30, K35980H30, K41457B30,
K37039A30, K37039B30, K42762B30, K37389A30, K38059A30
K38059B30, K38698B30, K38698C30, K38768A30 K39297A30,
K39998B30, K34942C60, K35980C60;
n) K36716A30;
o) K35037A25, K35037B25, K35037D25, K35372A25,
K35372C25, K38941B25, K39384B25, K35037C30,
K35372B30, K35372D30, K38383A30, K38941A30,
K39384A30, K39621A30, K40393A30;
p) K39025A25, K39111A25, K36425A30, K39092A30,
K39111B30, K39116A30;
q) K35730A25, K36777A25, K35730C30, K36777B30,
K37096A30, K38527A30, K38997A30;
r) K38387A25, K38376A30, K38387B30;
s) K33926R25, K34082A25, K34082B25, K36362A25,
K36362C25, K37410A25, K37761B25, K38379A25,
K38766A25, K40160A25, K40895B25, K33926R30,
K33926X30, K34082A30, K34082C30, K35376A30,
K35602C30, K36362B30, K36362D30, K42713B30,
K37410B30, K37761A30, K38379B30, K38766B30,
K38971A30, K38971B30, K39544A30, K39544B30,
K40160B30, K40895A30, K33926R60, K34082A60,
K35602A60, K35602B60;
t) K42222C30, K38539A30;
u) K39792A25, K36424A30, K41637B30, K41637A60,
K41066A60;
v) K43083R25, K43083R30;
w) K40067R25, K40781R25, K41163A25, K40067R30,
K40781R30, K41163A30;
x) K40033A25, K40154A25, K39426A30, K39640A,
K39865A30, K40033B30, K40154B30, K40154C30;
y) K36942R25, K37286A25, K38062A25, K42334A25,
K38338A25, K39140B25, K39349A30, K39349E25,
K39506B25, K39576A25, K40458A25, K36942R30,
K37286A30, K37692A30, K42334A30, K42421B30,
K38338B30, K38338C30, K39140A30, K39349B30,
K39349C30, K39349D30, K39506A30, K40458B30,
K40458C30, K40458D30;
z) K41366R25, K42022R25, K42371R25, K41366R30,
K42022R30, K42371R30;
aa) K41367R25, K41889R25, K42400R25, K43117R25,
K41368R30, K41367R30, K41889R30, K42400R30, K43117R30;
bb) K37715R25, K37715R30;
cc) K36399R25, K36687R25, K38797A25, K38797B25,
K36399R30, K36687R30, K37575A30, K38350A30, K36399R60,
K36399R90;
dd) K36347R25, K36626R25, K36347R30, K36626R30, K36347R60,
K36347R90;
ee) K36516R25, K41948A25, K38061B25, K38061C25, K38821C25,
K40563A25, K36516R30, K41948B30, K38061A30, K38306A30,
K38821A30, K38821B30, K40095A30, K40095B30, K40484A30;
ff) K42921R25, K42921R30;
gg) K37041A25, K38349A25, K38882A25, K37383A30, K38349B30,
K38349C30, K38882B30, K39296A30, K39296B30, K39507A30,
K42140B30;
hh) K36775B25, K37384A25, K38348A25, K39488A25, K40186A25,
K36775A30, K36775C30, K37384B30, K38348B30, K38788A30,
K38788B30, K42543B30, K43210A30, K39488B30, K40663A30;
ii) K37385A25, K38789B25, K39489B25, K37385B30, K38789A30,
K39078A30, K39078B30, K39489A30, K40187A30;
jj) K37125R25, K37473A25, K38101C25, K39620A25, K37125R30,
K37473A30, K38101A30, K38101B30, K42428A30, K39723A30;
kk) K40428B25, K37115R25, K38100A25, K38878A25, K40371A30,
K37115R30, K39405A30, K42685A30, K38878B30, K40428A30;
ll) K41315R25, K41678R25, K42378R25, K42892R25, K41315R30,
K41678R30, K42378R30, K42892R30;
mm) K42295R25, K42955R25, K41743R30, K42295R30, K42955R30;
nn) K34448A30, K34947A30, K35353A30, K35353B30, K36371A30,
K36371B30, K36371C30, K42794A30, K42910A30, K36625A30,
K36625C30, K36704A30, K36704B30, K36704C30, K37425A30,
K37425B30, K37733A30, K42420A30, K38608A30, K39417A30,
K34947B60, K35432A60, K35432B60, K36625B60, K36625D60;
oo) K36522R25, K36859A25, K37298B25, K37610B25, K37610C25,
K38981A25, K38982A25, K40008A25, K40894A25, K41256B25,
K36522R30, K36858A30, K36859A30, K37298A30, K37610,
K37610A30, K42077B30, K42714A30, K38317A30, K38317B30,
K38981B30, K39173A30, K40161A30, K40294A30, K40894B30,
K41256A30, K41256C30;
pp) K36115B30, K36115C30, K36115D30, K36115E30, K36352B30,
K36700B30, K37058A30, K37736A30, K38076A30, K39995A30,
K38864A30, K38864B30, K38864D30, K39088A30, K36115A60,
K36352A60, K36700A60, K38864C60, K39013A60;
qq) K37371C25, K37735A25, K41654A25, K37371A30, K37371B30,
K41654B30, K36810A60, K37735B60, K40368A60;
rr) K41479R25, K42059R25, K42410R25, K42973R25,
K41479R30, K42059R30, K42410R30, K42973R30;
ss) K36305A25, K36564A25, K37116A25, K37116B25,
K35833R30, K36305A30, K36564B30, K36944A30,
K36944B30, K35833R60, K36305A60;
tt) K35729A25, K35729E25, K35729F25, K36406C25,
K36705A25, K38547A25, K39003B25, K40580A25,
K40580C25, K36406B30, K36705B30, K36705C30,
K39003A30, K39543A30, K39543B30, K40580B30,
K40580D30, K35729D60, K35729B90;
uu) K36358B25, K36358D25, K38254A25, K38533B25,
K38745A25, K40875A25, K36358A30, K36358C30,
K36358E30, K38533A30, K38745B30, K40366A30;
vv) K37583, K38374B25, K38753A25, K40581A25,
K40917A25, K41578A30, K37583A30, K37583C30,
K38374A30, K38752A30, K38753B30, K39124A30,
K40581B30;
ww) K37012B25, K41418A25, K37012A30, K41418C60,
K41418D60, K40380A60, K34943A90, K41418B90,
K41621A90;
xx) K37416A25, K37874A30, K42000A30, K38372A30,
K39007A30, K40320A30, K41028A30;
yy) K42248R25, K42248R30;
zz) K41900R25, K42218R25, K41900R30, K42218R30,
K42800R30;
aaa) K37102A25, K39245A25, K36815A30, K37101A30,
K37102B30, K42687A30, K37102C60, K39245B60, K41854A60;
bbb) K41620A25, K41620B30, K38524A30, K38674A30, K42139A60,
K37061A90, K36797A90;
ccc) K36817A25, K36817B25, K36817C25, K38467A25, K37479A30,
K38467B30;
ddd) K36341R25, K42637R25, K42849R25, K36341R30, K42637R30,
K42948R30, K38972A30, K38972B30, K39542A30, K36341R60;
eee) K35608A25, K42131A25, K38876A25, K35350A30, K35608B30,
K35608C30, K38699A30, K38876B30, K38876C30, K41047A30;
fff) K42072A25, K38937A25, K38937B25, K38937X25, K42586A25,
K42970A25, K43114A25, K41026A25, K35854A30, K35854B30,
K35854C30, K35854D30, K38136A30, K38136B30, K38937C30,
K38937D30;
ggg) K34453B25, K35248A25, K41937A25, K42595A25, K40429A25,
K40931X25, K35248C30, K35248E30, K35248F30, K35617A30,
K35617B30, K41937B30, K43198B30, K37747A30, K38822A30,
K38822B30, K39771A30, K40429B30, K40931A30, K34453A60,
K35248B60;
hhh) K41975R25, K41975R30;
iii) K41497R25, K42035R25, K42297R25, K36949A25, K38269A25,
K40909R30, K41497R30, K42035R30, K42297R30, K37394A30,
K38269B30, K38269C30;
jjj) K40903R25, K41477R25, K41755R25, K42373R25, K43242R25,
K40903R30, K41477R30, K41753R30, K41755R30, K42373R30,
K43242R30;
kkk) K40646R25, K41266R25, K41752R25, K42372R25, K42880R25,
K40646R30, K41266R30, K41752R30, K42372R30, K42880R30;
lll) K38970A25, K41035A25, K38161A30, K38161B30, K38970B30,
K40395A30, K40395B30, K41035B30, K41359A30;
mmm) K42617R25, K43138R25, K42617R30, K43138R30;
nnn) K41518R25, K41974R25, K43078R25, K41518R30, K41517R30,
K41974R30, K43078R30;
ooo) K41922R30, K42589R30;
ppp) K42246R25, K42246R30;
qqq) K42949R25, K42949R30;
rrr) K41615X25, K42587A25, K39327R25, K39697A25, K40529C25, K41615A30,
K39327R30, K39697A30, K40376A30, K40529A30, K40529B30, K40529D30,
K40529E30;
sss) K36662A25, K36946A25, K43199A25, K38597A25, K39407A25, K40319A25,
K36662A30, K37111A30, K37111B30, K37111C30, K42405A30, K37576A30,
K38597B30, K39407B30;
ttt) K37060A25, K38660B25, K37060C30, K37060D30, K38660C30, K37060B60,
K38660A90;
uuu) K35547C25, K35547D25, K35547E25, K37015C25, K37016A25,
K35547A30, K37015A30, K42141A60, K35547B90;
vvv) K36711B25, K38831A25, K40475B25, K40475C25, K36711A30,
K36711C30, K37409A30, K37409B30, K38073A30, K38831B30,
K38661A30, K40293A30, K40475A30;
www) K42731R25, K42987R25, K43382R25, K42731R30, K42987R30,
K43381R30, K43382R30;
xxx) K43243R25, K43379R25, K43243R30, K43379R30;
yyy) K37037A25, K37037B25, K37392C25, K39770B25, K40100A25,
K36695A30, K37392A30, K37392B30, K39770A30, K40100B30,
K40157A30, K40157B30;
zzz) K43410R25, K43410R30;
aaaa) K34188A25, K34188B25, K34188C25, K37618R25, K41142B25,
K34188A30, K34188B30, K34188C30, K37618R30, K39617A30,
K42807A30, K40101A30, K40897A30, K41142A30;
bbbb) K34134R25, K34457R25, K35183R25, K35630R25, K35950R25,
K36342R25, K36661R25, K41884A25, K36958R25, K42829A25,
K37342R25, K40976A25, K34134R30, K34457R30, K35183R30,
K35630R60, K35950R30, K36342R30, K41419A30, K36661R30,
K36958R30, K37342R30, K39386A30, K34134R60, K34457R60,
K35183R60, K35630R60, K35950R60, K36342R60, K34134R90,
K34457R90, K35183R90, K35630R90, K35950R90, K36342R90;
cccc) K43143R25, K43143R30;
dddd) K40720R25, K41185R25, K41796R25, K42266R25, K42879R25,
K40720R30, K41185R30, K41796R30, K42266R30, K42879R30;
eeee) K41186R25, K41679R25, K41784R25, K42337R25, K42881R25,
K43463R25, K41186R30, K41784R30, K42337R30, K42881R30,
K42882R30, K43463R30;
ffff) K43017R25, K43017R30;
gggg) K41471R25, K41971R25, K42304R25, K43140R25, K41471R30,
K41971R30, K42304R30, K43140R30;
hhhh) K40814R25, K41293R25, K41921R25, K42812R25, K43448R25,
K40814R30, K41293R30, K41921R30, K42812R30, K43448R30;
iiii) K37036B25, K37458A25, K38543B25, K39084A25, K40522A25,
K36763A30, K37036A30, K37458B30, K37872A30, K38543A30,
K38772A30, K39084B30, K39920A30, K40522B30, K35545A60;
jjjj) K35034A25, K35988C25, K36266B25, K36266D25, K37043A25,
K37382B25, K41110B25, K35988E30, K35988F30, K36266C30,
K36266E30, K36266F30, K37382A30, K37746A30, K38318A30,
K40394A30, K41110A30, K35988A60, K35988B60, K36266A60,
K35988D90, K35988F90;
kkkk) K36701A30;
llll) K41270A25, K35702A30, K35702B30, K37068A30, K37068B30,
K39541A30, K41270B30, K40928A30;
mmmm) K42012R25, K42273R25, K42920R25, K41926R30, K42273R30,
K42920R30;
nnnn) K41187R25, K41798R25, K42323R25, K42890R25, K43464R25,
K41187R30, K41798R30, K42323R30, K42890R30, K43464R30,
K41187R60, K41798R60, K42323R60, K42890R60, K43464R60;
oooo) K36262B25, K36262D25, K37038A25, K37475A25, K38697A25,
K40134A25, K35028B30, K36262A30, K36262C30, K37475B30,
K37740A30, K38310A30, K38310B30, K38697B30, K39764A30,
K40134B30, K40134C30, K35028A60;
pppp) K34198A25, K37386B25, K39077B25, K39996A25, K42402A30,
K42596B30, K38047A30, K39077A30, K39996B30, K40472A30, K37040A,
K42596A60, K37386A60, K38047B60, K39240A60, K40472B60;
qqqq) K36296A25, K36764A25, K36764B25, K36764D25, K36764E25,
K37453A25, K38332B25, K38550A25, K36296B30, K36296C30,
K36764C30, K37073A30, K37073B30, K38316, K38332A30,
K39477A30, K39977B30, K40164A30, K34449A60;
rrrr) K33950A25, K34454B25, K35033B25, K35246A25, K36297A25,
K36297B25, K36297D25, K36776A25, K42597A25, K37739A25,
K38137B25, K38746C25, K39294A25, K40806B25, K40916A25,
K35033C30, K35246C30, K36297C30, K36297E30, K36776B30,
K42597B30, K37739B30, K37739C30, K37739D30, K38137A30,
K38746A30, K38746B30, K39368A30, K40167A30, K40806A30,
K34454A60, K34454C60, K35033A60, K35246B60, K35246D60;
ssss) K37070A30, K37070B30, K37465A30;
tttt) K36357B25, K38900B25, K38534A25, K40221A25, K40221B25,
K36357A30, K38900A30, K38900C30, K38534B30, K38534C30,
K38534D30, K39722A30, K40930A30, K41130A30;
uuuu) K37100A30, K37237A30, K37903A30, K41558A30, K42422A30,
K40427A30, K40427B30;
vvvv) K38099B25, K38099C25, K38535B25, K38099A30, K38535A30,
K38535C30, K39237A30, K39237B30, K39237C30, K39903A30,
K40474A30, K41153A30;
wwww) K38064A25, K35540B30, K37046A30, K37046B30, K38064B30,
K40856A30, K35540A60;
xxxx) K35377A25, K41613A25, K38939A25, K39725A25, K35377B30,
K35377C30, K38556A30, K38939B30, K40568A30, K40568B30;
yyyy) K35354A25, K41534A25, K36697A25, K36697B25, K37411C25,
K42918A25, K38754A25, K39238A25, K34560A30, K35354C25,
K35728A30, K41534B30, K41614A30, K37411A30, K37411B30,
K38074A30, K38074B, K38074C30, K38333A30, K38754B30,
K39366A30, K39366B30, K39616A30, K34560A60, K34560A90,
K35354B90;
zzzz) K34638A25, K34638C25, K35360A25, K35360B25, K36408A25,
K38542A25, K38542B25, K41120A25, K36408B30, K37741A30,
K38791A30, K39295A30, K39295B30, K39367A30, K34638B60;
aaaaa) K34372A25, K36698A25, K36698B25, K41965A25,
K37045B25, K35903A30, K36698C30, K36698D30, K37045A30,
K37045C30, K38095A30, K39490A30;
bbbbb) K40724R25, K41253R25, K41855R25, K42200R25,
K43018R25, K43357R25, K40724R30, K41253R30, K41855R30,
K42654R30, K43018R30, K43357R30;
ccccc) K37374A25, K40802A25, K37374A30, K40802B30,
K40920A30;
ddddd) K36741R25, K37114A25, K40218A25, K40218C25,
K40576A25, K40576C25, K36741R30, K37114A30, K40218B30,
K40576B30;
eeeee) K36740R25, K37137A25, K41580A25, K38818A25,
K39502B25, K40370B25, K40893A25, K36740R30, K37137A30,
K41580B30, K42683A30, K38334A30, K38818B30, K39502A30,
K39502C30, K39894A30, K40370A30, K40370C30, K40893B30;
fffff) K40575R25, K41291R25, K40575R30, K40575R30, K41291R30;
ggggg) K36770A25, K40483B25, K36770B30, K37584A30, K37584B30,
K38108A30, K39890A30, K40483A30, K40562A30, K41053A30;
hhhhh) K37585A25, K39000A25, K39997B25, K41143A25, K36694A30,
K36694B30, K37585B30, K38107A30, K38107B30, K39000B30,
K39460A30, K39997A30, K39997C30;
iiiii) K36706B25, K36706C25, K41529A25, K39001A25, K39622B25,
K36706A30, K36706D30, K37388A30, K37388B30, K38579A30,
K39001B30, K39622A30, K39622C30;
jjjjj) K43080R25, K43080R30;
kkkkk) K42010R25, K42010R30;
lllll) K37300A25, K38380A25, K38380B25, K42563A25, K38917A25,
K40163A25, K39087A25, K37300B30, K38085A30, K38917B30,
K39087B30, K39491A30, K40163B30, K40163C30;
mmmmm) K40098A25, K40098C25, K40700A25, K39630A30, K40098B30;
nnnnn) K42167A25, K42260A25, K42682A25, K38832A30, K38990A30,
K38990B30, K42167B30, K42260B30, K39975A30, K39975B30;
ooooo) K38830B25, K38048A25, K41655A25, K40162A25, K39403A30,
K38830A30, K38049B30, K38049C30, K40162B30, K40527A30,
K42559B30;
ppppp) K42721R25, K42821R25, K42721R30, K42821R30;
qqqqq) K37057B25, K40786A25, K41222A30, K37057A60, K40786B60;
rrrrr) K41603A25, K39408A25, K40471B25, K40859A25, K41603B30,
K38983A30, K40009A30, K40471A30, K40471C30;
sssss) K41292R25, K41890R25, K42219R25, K42797R25, K43375R25,
K41292R30, K41890R30, K42219R30, K42797R30, K43375R30;
ttttt) K41159R25, K41720R25, K42293R25, K42816R25, K43377R25,
K41159R30, K41720R30, K42293R30, K42816R30, K43377R30;
uuuuu) K42015R25, K42374R25, K43085R25, K42015R30, K42374R30,
K43085R30;
vvvvv) K41924R25, K42397R25, K43240R25, K41923R30, K41924R30,
K42397R30, K43240R30;
wwwww) K37578A25, K38707A25, K39466A25, K39976B25, K39976C25,
K37578B30, K38081A30, K38081B30, K38557A30, K38707B30,
K38707C30, K39976A30;
xxxxx) K41365R25, K42247R25, K42817R25, K41365R30, K42247R30,
K42817R30;
yyyyy) K41137A25, K39455A30, k39455b30, K39624A30, K43159B30,
K40524A30, K41137B30;
zzzzz) K38536A25, K42359A25, K42644A25, K37011A30, K37056A30,
K37056B30, K37056C30, K38045A30, K38045B30, K41979A30,
K41980A30, K41981A30, K42109A30, K38353A30, K38956A30;
aaaaaa) K42399A25, K39526A30, K36710X30, K37071B30, K36710A60,
K37071A60;
bbbbbb) K34103A25, K34500A25, K35534B25, K35982B25, K35982C25,
K41936A25, K42419A25, K43179A25, K38785A25, K40978A25,
K36409A30, K36409B30, K41936B30, K38307A30, K38307B30,
K38785B30, K39293A30, K39371A30, K39991A30, K39991B30,
K34103A60, K34500B60, K35534A60, K35982A60;
cccccc) K36349B25, K37387B25, K39326A25, K40882A25, K40882X25,
K35031A30, K35031B30, K35366A30, K35366C30, K36349A30,
K41417A30, K36708A30, K37387A30, K37387C30, K38855A30,
K39326B30, K39983A30, K39983B30, K40882B30, K35031B60,
K35366B60;
dddddd) K34914A25, K35744A25, K36264C25, K36264D25, K36264E25, K36264F25, K36264H25, K42136A25, K42708A25, K38708B25, K39922A25, K39922B25, K40884X25, K34914B30, K35536B30, K35744B30, K36264B30, K36264G30, K38060A30, K38060B30, K38708A30, K39292A30, K39922C30, K40884A30, K35536A60, K36264A60, K35536A90;
eeeeee) K42267R25, K43232R25, K42267R30, K43232R30;
ffffff) K42974R25, K42974R30;
gggggg) K41969R25, K42259R25, K42808R25, K41969R30, K42259R30,
K42808R30;
hhhhhh) K43156R25, K43156R30;
iiiiii) K37103A30, K38386A30;
jjjjjj) K41470R25, K41827R25, K42501R25, K42925R25, K41470R30,
K41827R30, K41828R30, K42501R30, K42925R30;
kkkkkk) K42588A60, K42188A90;
llllll) K37591A30, K37591B30, K38149A30, K41225A60, K41318A60;
mmmmmm) K36805B25, K36805A60;
nnnnnn) K40323A25, K38035R30, K40323B30;
oooooo) K37477A30, K37477B60;
pppppp) K39277R25, K41058A25, K39277R30, K41058B30;
qqqqqq) K37451B25, K36534R30, K37451A30, K38075A30, K41659A30,
K42071A30, K41565A30, K36534R60;
rrrrrr) K37979R25, K38408R25, K38635R25, K40838A25, K42189A30,
K37979R30, K39528A30, K38408R30, K38635R30, K39527A30,
K39904A30, K40838B30;
ssssss) K36205R25, K36535R25, K36205R30, K36535R30, K36941R30,
K37577a30, K42404A30, K36205R60;
tttttt) K43374R25, K42857A30, K43374R30, K43286R30;
uuuuuu) K41188R25, K42112R25, K42636R25, K43045R25, K41188R30,
K42112R30, K42636R30, K43045R30;
vvvvvv) K42618R25, K42618R30;
wwwwww) K35600A25, K36104B25, K36361B25, K36361D25, K36665B25,
K38790A25, K40896B25, K41424A25, K39898B25, K39898C25, K41121A25,
K36361A30, K36361C30, K36361D30, K36665A30, K36665C30, K36665D30,
K37354A30, K38305A30, K38305B30, K38790B30, K39083A30, K40896A30,
K40896C30, K41424B30, K39898A30, K39898D30, K40311A30, K40311B30,
K42706A30, K40785A30, K41121B30, K35600B60, K35600C60, K36104A60;
xxxxxx) K41157R25, K41917R25, K42292R25, K42818R25, K43352R25,
K41157R30, K41916R30, K41917R30, K42292R30, K42444R30,
K42818R30, K43352R30;
yyyyyy) K41552R25, K42032R25, K42409R25, K43136R25, K42031R30,
K41552R30, K42032R30, K42409R30, K43136R30;
zzzzzz) K41354R25, K41681R25, K42173R25, K43004R25, K43353R25,
K41354R30, K41681R30, K42173R30, K42443R30, K42755R30,
K43004R30, K43353R30;
aaaaaa) K36343R25, K41107A25, k36343r30, k36343r60, K41951A60;
bbbbbbb) K35940R25, K36220R25, K39144A25, K35906R30, K35940R30,
K36220R30, K38613A30, K35940R60, K36220R60;
ccccccc) K42307R25, K42798R25, K42307R30, K42798R30;
ddddddd) K43013R25, K43013R30;
eeeeeee) K37452A25, K39114A25, K40861A25, K37452B30, K37452C30,
K38097A30, K38633A30, K39467A30, K39467B30, K40861B30,
K40861C30, K42190A30, K42553A30, K43216B30;
fffffff) K37109A25, K37109B30, K37455A30, K39089A30, K43027A30,
K43030A30, K40423A30;
ggggggg) K40927A25;
hhhhhh) K41586R25, K42615R25, K42975R25, K43449R25,
K41586R30, K42615R30, K42975R30, K43449R30;
iiiiiii) K41355R25, K42243R25, K42819R25, K43450R25, K41355R30,
K42016R30, K42243R30, K42819R30, K43450R30;
jjjjjjj) K43061R25, K43061R30;
kkkkkkk) K42883R25, K42883R30;
lllllll) K35601C25, K36395A25, K38262B25, K38795B25, K38862A25,
K38862B25, K40378B25, K40860A25, K35601D30, K36395B30,
K36395C30, K36395D30, K38262A30, K39145A30, K42431B30,
K38795A30, K39769A30, K39769B30, K40378A30, K40860B30,
K35601B60, K35601B90;
mmmmmmm) K34079A25, K34079C25, K34079E25, K37084A25,
K41938A25, K42561A25, K43054A25, K39383A25, K39798B25,
K40295A25, K40971A25, K34079A30, K37084B30, K37084C30,
K37047A30, K39383B30, K39798A30, K40295B30, K34079A60,
K34079B60, K34079D60;
nnnnnn) K37048B25, K37370A25, K37370C25, K38065A25,
K42598A25, K39387B25, K40310A25, K41119A25, K37048A30,
K37370B30, K38065B30, K42159A30, K42598B30, K38757A30,
K38757B30, K39387A30;
ooooooo) K35851A25, K35851E25, K36699A25, K37395C25,
K38501A25, K38540A25, K39085A25, K39992B25, K41012B25,
K41118A25, K35851D30, K35851F30, K35851G30, K36699B30,
K36699C30, K36699D30, K37395A30, K37395B30, K37765A30,
K38501B30, K38540B30, K39992A30, K40407A30, K41012A30,
K41118B30, K35851C60, K35851B90;
ppppppp) K35637B25, K37013B25, K37013D25, K41662A25,
K41953A25, K41954A25, K42584A25, K38163A25, K43112A25,
K40408C25, K40886X25, K41034A25, K37013C30, K41662C30,
K42584C30, K38163B30, K40886A30, K35637A60, K35637C60,
K35637D60, K37013A60, K41662B60, K43112B60, K40408A60,
K40408B60;
qqqqqqq) K43263R25, K43263R30;
rrrrrrr) K38553C25, K39864B25, K38553A60, K38553B30, K39864A60,
K40178A60;
sssssss) K42142A25, K38507R25, K38666R25, K39444A25,
K42142B30, K42763B30, K38507R30, K38666R30, K39444B30,
K40180A30, K40369A30, K40369B30, K40369C30;
ttttttt) K35412R25, K35674R25, K35947R25, K36322R25, K37086B25,
K37086C25, K38080B25, K40525A25, K35412R30, K35660R30,
K35674R30, K35947R30, K36322R30, K37086A30, K37087A30,
K42831B30, K37459A30, K37758A30, K38080A30, K38879A30,
K39437A30, K39437B30, K40525B30, K36322R60;
uuuuuuu) K34023R25, K34083A25, K36426B25, K37098A25,
K38955A25, K38339A25, K34023R30, K34083B30, K36426A30,
K36709A30, K38897A30, K38898A30, K39525A30, K34023R60,
K34083A60, K34023R90, K34083A90;
vvvvvvv) K41498R25, K42548R25, K43139R25, K41498R30, K42548R30,
K43139R30;
wwwwwww) K37381A25, K41081A25, K37381B30, K37690A30,
K37822A30, K37822B30, K42686A30, K39075A30, K39075B30,
K39410A30, K39410B30, K39410C30;
xxxxxxx) K36778B25, K37461A25, K37461B25, K41480R25, K42066R25,
K42244R25, K43135R25, K36778A30, K41480R30, K42062R30,
K42066R30, K42244R30, K43135R30;
yyyyyyy) K41092R25, K34450A25, K41705R25, K42401R25, K42894R25,
K41092R30, K41705R30, K42401R30, K42893R30, K42894R30,
K36830R30, K37193R30;
zzzzzzz) K37545R25, K39250R25, K39688R25, K40039R25, K35669A25,
K43274A25, K33935A30, K37545R30, K39250R30, K39688R30,
K40039R30, K35669C30, K41364A30, K33935A60, K35645A60,
K35669B60;
aaaaaaaa) K34637B25, K35856A25, K34205A30, K34371A30,
K34637A30, K34999A30, K35856B30, K36427A30, K36427B30,
K36427C30;
bbbbbbbb) K38787A25, K40979A25, K39186A30, K39186B30,
K39861A30, K39861B30, K39861C30, K39861D30;
cccccccc) K34102A25, K34519A25, K34519C25, K34519E25, K35365A25,
K38434B25, K38612E25, K38612F25, K38612J25, K33958A30,
K34102A30, K34519F30, K35365B30, K35365C30, K35365D30,
K37748A30, K37748B30, K38434A30, K38434C30, K38612A30,
K38612C30, K38612D30, K38612G30, K38612H30, K34102A60,
K34519B60, K34519D60, K33958A90;
dddddddd) K36263A30, K36263B30, K37044A30, K38694A30, K40392A30,
K40392B30, K40982A30;
eeeeeeee) K37647A25, K38706A25, K38706B25, K37647A30, K38160A30,
K38706C30, K39862A30;
ffffffff) K39533B25, K42971A25, K40609A30, K41653A30, K42119A30,
K39533A30;
gggggggg) K40250R25, K41472A25, K40250R30, K41472A30;
hhhhhhhh) K35370B25, K35606A25, K36374B25, K36374C25, K36374D25,
K41819A25, K42153A25, K37460A25, K35370A30, K35606B30, K35606C30,
K36374A30, K36374E30, K36374F30, K42153B30, K37110A30, K38382A30,
K38828A30, K38828B30;
iiiiiiii) K37052B30, K37052C30, K38066A30, K40887A30, K41111A30, K37052A90;
jjjjjjjj) K35649A25, K35649B25, K35649D25, K39682B25, K39682C25, K40410B25,
K41011A25, K41108A25, K42407A30, K38068A30, K39682A30, K40410A30,
K40410C30, K40885A30, K41011B30, K35026A60, K35026B90, K35649C90;
kkkkkkkk) K34998B25, K34998C25, K35374B25, K35374E25, K35374F25,
K36768C25, K38940A25, K38940B25, K40377C25, K34998D30, K34998E30,
K35374C30, K36768A30, K36768B30, K37403A30, K38067A30, K38067B30,
K38067C30, K39892A30, K39892B30, K40377A30, K40377B30, K40377D30,
K35374A60, K35374D60, K34998A90;
llllllll) K34558B25, K36118E25, K36118F25, K41415A25, K36773A25, K38765B25,
K40409A25, K40409C25, K36118A30, K36118C30, K36118D30, K36118G30,
K41415B30, K37049A30, K38765A30, K38765C30, K40409B30, K36118B60,
K34558A90
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by letter dated July 28, 2006. Firm initiated recall is ongoing.
REASON
.Mispacked; correct labeled product may be mispacked.
VOLUME OF PRODUCT IN COMMERCE
717,755 units
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Terazosin Hydrochloride capsules, 10 mg, 1000-capsule bottle, Rx only, NDC 59746-386-10, Recall # D-410-7
CODE
Lot 6F004, exp. 06/2008
RECALLING FIRM/MANUFACTURER
Jubilant Pharmaceuticals Inc., Salisbury, MD, by e-mail and telephone on September 22, 2006. Firm initiated recall is ongoing.
REASON
May contain capsules with color and marking for Terazosin Hydrochloride 1 mg capsules ("TL 383"). The content of the mis-identified capsules has been tested and found to contain 10 mg Terazosin Hydrochloride as labeled.
VOLUME OF PRODUCT IN COMMERCE
960/1000 capsule bottles
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0010-7;
b) Fresh Frozen Plasma, Recall # B-0011-7
CODE
a) and b) Unit: FW82106
RECALLING FIRM/MANUFACTURER
Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by facsimile on July 6, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured from an overweight unit of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0033-7
CODE
53LF82627 (part 1)
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone On September 5, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Source Plasma, Recall # B-0054-7
CODE
Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
CA and Austria

______________________________
PRODUCT
Red Blood Cells, Recall # B-0055-7
CODE
Unit: 1170906
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by letter dated June 21, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Fresh Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0056-7
CODE
Units: 53GK37120 (parts 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone and by letter dated March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0057-7
CODE
Unit: 53LF79988 (part 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by letter dated March 14, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0058-7
CODE
Unit: 53LT87457
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on March 21, 2005 and by letter dated March 30, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.

______________________________
PRODUCT
a) Red Blood Cells, Recall # B- 0059-7;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0060-7;
c) Fresh Frozen Plasma, Recall # B-0061-7;
d) Plasma, Cryoprecipitate Reduced, Recall # B-0062-7;
e) Platelets, Recall # B-0063-7;
f) Cryoprecipitated AHF, Pooled, Recall # B-0064-7;
CODE
a) Units: 0618126, 0300011, 0435473;
b) Unit: 1056384;
c) Unit: 0618126;
d) Units: 09012518, 9010640;
e) Units: 0300011, 0435473;
f) Unit: 09012518
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by letter dated July 7, 2004 or July 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to Hepatitis C virus (anti-HCV), but were collected from a donor who previously tested positive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
FL and MN

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0066-7;
b) Cryoprecipitated AHF, Recall # B-0067-7;
c) Plasma, Cryoprecipitate Reduced, Recall # B-0068-7
CODE
a) Units: 8666007, 0132068, 0523797;
b) Units: 0523797, 0132068, 8666007;
c) Unit: 0523797
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by letter dated July 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MN

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0070-7;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0071-7;
c) Cryoprecipitated AHF, Recall # B-0072-7;
d) Platelets, Recall # B-0073-7;
e) Recovered Plasma, Recall # B-0074-7
CODE
a) Units: 53FM34504, 53FM36697, 53GJ19101, 53KK06088,
53KM39316;
b) Units: 53FK68042, 53FK69388;
c) Unit: 53FM36697;
d) Unit: 53GJ19101;
e) Units: 53FK68042, 53FK69388, 53FM34504, 53FM36697,
53GJ19101, 53KK06088, 53KM39316
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by letter and e-mail on April 16, 2004, May 19, 2004, and June 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred for a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA, MD, VA, D.C., and Switzerland

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0077-7
CODE
Unit: 53LP52167 (part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by letter dated August 12, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Rad Sure Blood Irradiation Indicators, Recall # B-0078-7
CODE
Lot Numbers: O15811XR, O15816XR, 015811X15, 015814X15, 015819X15, 015823X15
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Specialty Products, Inc., Wayne, NJ, by letter dated July 21, 2006.
Manufacturer: Kent Adhesive Products Company, Kent, OH. Firm initiated recall is complete.
REASON
Radiation stickers, which did not darken following irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
823 boxes of 200 each
DISTRIBUTION
Nationwide and Japan

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0102-7
CODE
Unit: 53FJ02995
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Baltimore, MD, by telephone and by letter dated October 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0103-7
CODE
Unit: 53GQ25220
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Baltimore, MD, by telephone and by letter dated December 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0104-7
CODE
Unit: 53LF83655
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Baltimore, MD, by telephone and by letter dated November 30, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0106-7
CODE
Unit: LJ90713
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated June 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0107-7
CODE
Unit: LV13961
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by telephone on August 27, 2004 and by letter dated October 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0108-7;
b) Platelets Irradiated, Recall # B-0109-7
CODE
a) Units: KK52283, and KL80518;
b) Unit: KL80518
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated March 17, 1998. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
VA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0110-7
CODE
Unit: 29FN57848
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Norfolk, VA, by telephone on June 2, 2005 and by letter dated June 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0111-7
CODE
Unit: 2466272 (Part B)
RECALLING FIRM/MANUFACTURER
Walter Reed Army Medical Center, Washington, D.C., by telephone on August 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0112-7
CODE
Unit: 2466603 (Part B)
RECALLING FIRM/MANUFACTURER
Walter Reed Army Medical Center, Washington, D.C., by telephone on December 23, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0113-7
CODE
Unit: 5115530 (split)
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Bank, Augusta, GA, by telephone on May 18, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Plasma Frozen Cryoprecipitate Reduced, Recall # B-0120-7
CODE
Unit: L67721
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on April 10, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who tested positive for the antibody to the hepatitis C virus (anti-HCV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
Source Plasma, Recall # B-0121-7
CODE
Units: RZ013603, RZ014423, RZ014865, RZ014997, 05HINB0760, 05HINB0807, 05HINB0970, 05HINB1224, 05HINB1653, 5HINB2116 and 06HINA2400
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by facsimile on April 14, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of being incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
CA and Austria
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS- - CLASS III

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0029-7
CODE
Units: 4033698B 4034060C 4047973A 4047973B 4048215B 4048215C 4051012A
4051667B 4051667C 4059451B 4059451C 4060152A 4060152C 4061755B 4069909A
4070648B 4070648C 4071461B 4071461C 4071619B 4071620A 4071620B 4071620C
4071793C 4071905A 4071905C 4072098B 4072098C 4072121A 4072121B 4072554B
4072806A 4072806B 4073010B 4073010C 4073555A 4073617A 4073872A 4073872B
4074791B 4075266A 4075286A 4075600B 4075948A 4076612C 4077051A 4077297B
4077400A 4077400B 4077400C 4078386A 4078507C 4078837C 4079819A 4080066B
4080867A 4080867B 4080867C 4081046A 4081434A 4081434B 4081434C 4081564B
4081564C 4082443A 4082443B 4082443C 4082461A 4082461C 4082766B 4082815B
4083259A 4083259B 4083443A 4083443B 4083572A 4083572B 4083572C 4083795A
4083795C 4084199B 4084199C 4084714A 4084714B 4085441A 4085441B 4085515A
4085515B 4085515C 4085740A 4085996B 4085996C 4086302A 4086302B 4086302C
4086496B 4086496C 4086885B 4086891A 4086891B 4086891C 4720230B 4720230C
4720352A 4720352B 4721062A 4721062B 4721062C 4722321A 4722480A 4723181A
4723223B 4726042A 4726042B 4727340A 4727360C 4727414A 4727414C 4727553A
4727553C 4728132B 4728132C 4728343C 4728543C 4728598A 4728598B 4728598C
4728941C
4728993B 4729046C 4729056A 4729056B 4729056C 4729118A 4729118B 4729118C
4729119C 4729341A 4729341C 4729447A 4729509A 4729509C 4729521B 4729586A
4729586B 4729586C 4729618A 4729648C 4729717B 4729798C 4729816A 4729891A
4730113B 4730151A 4730151C 4730216B 4730541C 4730656C 4730771B 4730771C
4730846C 4730926B 4730935A 4730935B 4731043A 4731043C 4731241A 4731443B
4731443C 4731448A 4731544C 4731622A 4731622C 4731764B 4731904A 4731904B
4731904C 4731936A 4731936B 4732006C 4732014A 4732038A 4732038C 4732068C
4732092A 4732092B 4732092C 4732115C 4732158A 4732158B 4732159A 4732159B
4732200B 4732224A 4732224B 4732229A 4732377A 4732377B 4732377C 4732378B
4732378C 4732379B 4732379C 4732413B 4732413C 4732435B 4732441A 4732441C
4732467A 4732467C 4732636A 4732636C 4732697B 4732697C 4732805B 4732805C
4732945A 4732945C 4732984B 4732984C 4733134B 4733134C 4733135B 4733135C
4733329A 4733329B 4733408A 4733408B 4905705B 4907537A 4907609A 4908691A
4908691B 4908691C 4912500A 4914345B 4916674A 4916674C 4916925A 4916925B
4916925C 4917026C 4917187A 4917678C 4918622B 4918780B 4918826A 4918826B
4918843A 4918843B 4918845B 4919085C 4919115A 4919124B 4919124C 4919229B
4919229C 4919236B 4919319B 4919319C 4919325C 4919327A 4919347A 4919347B
4919485A 4919567A 4919567C 4919569B 4919570A 4919570B 4919622B 4919642A
4919642B 4919642C 4919702B 4919702C 4919808B 4919971B 4920080B 4920086A
4920230A 4920332A 4920332B 4920332C 4920404C 4920611A 4920611C 4920769B
4920954A 4920956A 4920956C 4921041A 4921041B 4921041C 4921064A 4921064C
4921267B 4921267C 4921286A 4921286B 4921286C 4921312A 4921312C 4921347B
4921366A 4921374A 4921427C 4921445C 4921520A 4921520B 4921520C 4921625A
4921625B 4921625C 4921659B 4921659C 4921844A 4921844B 4921844C 4921935A
4921935B
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center, Pensacola, FL, by letters dated March 21, 2006, August 14, 2006, and August 17, 2006. Firm initiated recall is complete.
REASON
Unlicensed blood products were distributed in interstate commerce.
VOLUME OF PRODUCT IN COMMERCE
321 units
DISTRIBUTION
AL, IN, MS, TN, and NJ

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0052-7;
b) Fresh Frozen Plasma, Recall # B-0053-7
CODE
a) and b) Unit: J21587
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on January 16, 2006, and by
letter dated January 17, 2006. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA

______________________________
PRODUCT
Recovered Plasma, Recall # B-0065-7
CODE
Unit: 1056384
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by facsimile on June 25, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to Hepatitis C virus (anti-HCV), but were collected from a donor who previously tested positive for anti-HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Recovered Plasma, Recall # B-0069-7
CODE
Unit: 0132068
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by letter dated July 20, 2004. Firm initiated recall is complete.
REASON
Blood product which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested reactive for the antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Copper Sulfate Solution (8.3% ACS Reagent Grade Copper Sulfate
Pentahydrate in ACS Reagent Grade Water) 500 mL;
Specific Gravity = 1.053 at 25 C, Recall # B-0075-7
CODE
Lot Number: 2508266
RECALLING FIRM/MANUFACTURER
Ricca Chemical Company, Arlington, TX, by letters dated September 27, 2005.
Firm initiated recall is complete.
REASON
Copper Sulfate, with a low specific gravity, was distributed.
VOLUME OF PRODUCT IN COMMERCE
36
DISTRIBUTION
NM, NY, PA, GA and NJ

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0116-7
CODE
Units: 12KJ22979 (split)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on December 25, 2005. Firm initiated recall is complete.
REASON
Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0119-7
CODE
Unit: 12FP90273
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by letter dated January 11, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receipt of post donation information that the donor was diagnosed with anemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall # Z-0022-2007
CODE
Model 8627-10, serial numbers: NGE000001 - NGE000242R,
Model 8627-18, serial numbers: NGF000001 - NGF003266R,
Model 8627L-10, serial numbers: NGG000001R - NGG000068R,
Model 8627L-18, serial numbers: NGH000001R - NGH001780R
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN, by letter beginning June 6, 2006.
Manufacturer: Medtronic, Inc. Cardiac Rhythm Management, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.
VOLUME OF PRODUCT IN COMMERCE
4,317 pumps
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed, Recall # Z-0026-2007
CODE
Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Extended Care Air Therapy Systems Inc, Roseville OH, by letter on April 5, 2006 and by follow-up letters in May and June.
Manufacturer: GF Health Products, Inc., Fond Du Lac WI. Firm initiated recall is complete.
REASON
Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall.
VOLUME OF PRODUCT IN COMMERCE
102 beds
DISTRIBUTION
KS, TN, MI, PA, and LA

______________________________
PRODUCT
BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm, Catalog number 367352, Catalog number 367352, Catalog number 367352, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Recall # Z-0034-2007
CODE
Lot # 6100596, Lot # 6100597, Lot # 6152413, Lot # 6090251, Lot # 6094813, Lot # 6094840, Lot # 6111757, Lot # 6121663, Lot # 6146186
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ, by letter on August 24, 2006.
Manufacturer: BD Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.
REASON
A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.
VOLUME OF PRODUCT IN COMMERCE
110,300 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Medline Strider Maxi 3 Scooter; a three wheeled battery
operated scooter; model MDS807600 - red and MDS807600B --
blue, Recall # Z-0036-2007;
b) Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter;
model MDS807650 - red and MDS807650B -- blue, Recall # Z-0037-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries, Inc., Mundelein, IL, by letters dated July 20, 2006.
Manufacturer: Changzhou Kwang Yang Motor Co., Ltd, Changzhou, Jangsu, China. Firm initiated recall is ongoing.
REASON
Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
VOLUME OF PRODUCT IN COMMERCE
296 scooters
DISTRIBUTION
Nationwide

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PRODUCT
a) Eagle Parts and Products Model 624EZ Power Wheel Chairs with
internally threaded wheel mount motors, Recall # Z-0039-2007;
b) Eagle Parts and Products Model 624Mini Power Wheel Chairs with
internally threaded wheel mount motors, Recall # Z-0040-2007
CO/DE
Serial numbers 624EZ0010 through 624EZ0513
RECALLING FIRM/MANUFACTURER
Eagle Parts and Products, Augusta, GA, by letters on July 11, and 28, 2006. Firm initiated recall is ongoing.
REASON
The wheel hub bolts may loosen resulting in the wheels coming off.
VOLUME OF PRODUCT IN COMMERCE
365 units
DISTRIBUTION
Nationwide

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PRODUCT
GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210, Recall # Z-0041-2007
CODE
Serial numbers E9-0002-G, E9-0004-G, E9-0014-G, E9-0032-G, E9-0035-G, E9-0036-G, E9-0040-G, E9-0041-G, E9-0042-G, ES-0002-G, ES-0003-G, ES-0013-G, ES-0014-G, ES-0015-G, ES-0016-G, ES-0018-G, ES-0020-G, ES-0021-G, ES-0023-G, ES-0024-G, ES-0025-G, ES-0026-G, ES-0027-G, ES-0028-G, ES-0031-G, ES-0032-G, ES-0033-G, ES-0034-G, ES-0035-G, ES-0040-G, ES-0041-G, ES-0042-G, ES-0043-G, ES-0044-G, ES-0081-G, ES-0082-G, ES-0083-G, ES-0084-G, ES-0085-G, ES-0086-G.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter beginning September 30, 2006. Firm initiated recall is ongoing.
REASON
Missing, mixed or lost patient images may result after X-ray procedures. Navigational error.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, Recall # Z-0042-2007
CODE
Serial numbers: E2-0001 thru E2-0065, E2-0066-CH, E2-0067 thru E2-0152, E2-0156 thru E2-0159, E2-0166, E2-7001-MH thru E2-7033-MH, E2-7034-CMH, E2-7035-MH thru E2-7056-MH, E9-0001, E9-0003, E9-0005 thru E9-0013, E9-0015 thru E9-0031, E9-0033, E9-0034, E9-0038, E9-0039, E9-0043 thru E9-0082, E9-00084, E9-0086, E9-0087, E9-0096, E9-0097, E9-0104, E9-0105, E9-0106, E9-0107, ES-0001, ES-0004, ES-0005, ES-0006, ES-0007-C, ES-0008, ES-0009, ES-0010, ES-0011-H, ES-0012-H, ES-0017, ES-0019, ES-0022-CH, ES-0029-CH, ES-0030, ES-0036-CH, ES-0037, ES-0038, ES-0039, ES-0045-H, ES-0046-CH, ES-0047, ES-0048, ES-0049-H, ES-0050 thru ES-0059, ES-0060-H, ES-0061, ES-0062-H, ES-0063-H, ES-0064, ES-0065, ES-0066-CH, ES-0067 thru ES-0080, ES-0091-H, ES-0092-CH, ES-0093, ES-0094, ES-0095, ES-0096, ES-0099-CH, ES-0100-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0106, ES-0107, ES-7001-CMH, ES-7002-MH, ES-7003-MH, ES-7004-CMH, ES-7005-MH, ES-7006-CMH thru ES-7013-CMH, ES-7014-MH thru ES-7018-MH, ES-7019-CMH, ES-7020-CMH, ES-7022-CMH, ES-7023-CMH, ES-7024-CMH, ES-7025-CMH, ES-7026-MH, ES-7027-MH.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter beginning September 29, 2006. Firm initiated recall is ongoing.
REASON
X-ray system may lose or mix images and/or lose patient data.
VOLUME OF PRODUCT IN COMMERCE
388 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45, Recall # Z-0043-2007
CODE
Lot number: S2964090
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioplate Inc, Los Angeles CA, by telephone on September 14, 2006 and by letter on September 16, 2006
Manufacturer: Midwest Plastic Components, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide

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PRODUCT
0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex, Recall # Z-0044-2007
CODE
Lot: 22-010-9D
RECALLING FIRM/MANUFACTURER
Excelsior Medical Corp., Neptune, NJ, by letter on April 24, 2006 and April 28, 2006. Firm initiated recall is complete.
REASON
The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
VOLUME OF PRODUCT IN COMMERCE
466,000 syringes
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Doc-U-Dose Prescription Management System, Item #8-PKIT, a daily activity assist device under 21 C.F.R. 890.5050. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime,'' Recall # Z-0045-2007
CODE
Four (4) lot codes are subject to recall: 312733, 312734, 313767, and 313768. This accounts for all of the Doc-U-Dose packets distributed by the firm since May 13, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eatonform, Inc., Dayton, OH, by letters on August 2, 2006, August 4, 2006, and August 11, 2006.
Manufacturer: Ward/Kraft, Inc., Fort Scott, KN. Firm initiated recall is ongoing.
REASON
Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.
VOLUME OF PRODUCT IN COMMERCE
913 devices
DISTRIBUTION
Nationwide

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PRODUCT
Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN 1018246, Recall # Z-0047-2007
CODE
Serial numbers: VSF5200456 VSF5200470 VSF5200474 VSF5200491 VSF5200520 VSF5200521 VSF5200524 VSF5200529 VSF5200534 VSF5200190 VSF5200224 VSF5200235 VSF5200292 VSF5200302 VSF5200319 VSF5200325 VSF5200338 VSF5200345 VSF5200350 VSF5200351 VSF5200353 VSF5200355 VSF5200356 VSF5200460 VSF5200511 VSF5200512 VSF5200530 VSF5200535 VSF5200536 VSF5200538 VSF5200542 VSF5200545 VSF5200548 VSF5200552 VSF5200553 VS3007083 VS3007154 VS3007171 VSF5200343 VSF5202005 VS3005661 VS3008643 VS3008863 VS3008976 VS3006424 VS3007284 VS3007684 VS3008702 VS3008781 VS3007757 VS3008853 VS3008945 VS3008989 VSF5200297 VSF5200340 VSF5200344 VSF5200406 VSF5201510 VSF5202096 VS3004635 VS3004813 VS3005642 VS3005696 VS3005810 VS3005897 VS3005945 VS3006191 VS3006213 VS3006220 VS3006385 VS3006546 VS3006549 VS3006578 VS3006584 VS3006587 VS3007199 VS3007215 VS3007296 VS3007304 VS3007397 VS3007512 VS3007712 VS3007715 VS3007771 VS3007777 VS3007823 VS3007834 VS3007896 VS3007908 VS3008558 VS3008567 VS3008646 VSF5200352 VSF5200363 VSF5200373 VSF5200380 VSF5200382 VSF5200391 VSF5200392 VSF5200240 VSF5200303 VSF5200317 VSF5200322 VSF5200327 VSF5200328 VSF5200330 VSF5200336 VSF5200407 VSF5200540 VSF5200541 VSF5200547 VSF5200551 VSF5200554 VSF5200556 VSF5200569 VSF5200570 VSF5200623 VSF5200632 VSF5200634 VSF5200637 VSF5200638 VSF5200641 VSF5200648 VSF5200789 VSF5200793 VSF5200796 VSF5200799 VSF5200802 VSF5200805 VSF5200807 VSF5200808 VSF5200809 VSF5200810 VSF5200811 VSF5200812 VSF5200813 VSF5200815 VSF5200817 VSF5200818 VSF5200819 VSF5200820 VSF5200823 VSF5200824 VSF5200825 VSF5200827 VSF5200836 VSF5200839 VSF5200842 VSF5200846 VSF5201231 VSF5201242 VSF5201254 VSF5201255 VSF5201256 VSF5201258 VSF5201273 VSF5201557 VS3004805 VS3006192 VS3006193 VS3006194 VS3006195 VS3006202 VS3006206 VS3006211 VS3006219 VS3006333 VS3006337 VS3006349 VS3006386 VS3006394 VS3006396 VS3006399 VS3006400 VS3006402 VS3006408 VS3006414 VS3006421 VS3006637 VS3007177 VS3007292 VS3007429 VSF5200293 VSF5200305 VSF5200308 VSF5200313 VSF5200316 VSF5200321 VSF5200348 VSF5200354 VSF5200359 VSF5200364 VSF5200369 VSF5200400 VSF5200404 VSF5202388 VS3004803 VS3004916 VS3005626 VS3005797 VS3005852 VS3005865 VS3005902 VS3005984 VS3006200 VS3006218 VS3006634 VS3007103 VS3007542 VS3007545 VS3007605 VS3007620 VSF5200276 VSF5200294 VSF5200298 VSF5200301 VSF5200306 VSF5200312 VSF5200314 VSF5200318 VSF5200333 VSF5200337 VSF5200349 VSF5200361 VSF5200398 VSF5200402 VSF5200450 VSF5200457 VSF5200466 VSF5200468 VSF5200469 VSF5200472 VSF5200492 VSF5200496 VSF5200537 VSF5200546 VSF5200549 VSF5200571 VSF5200608 VSF5200611 VSF5200615 VSF5200625 VSF5200628 VS3006533 VS3006642 VS3007477 VS3007485 VS3007486 VS3007540 VS3007546 VS3007564 VS3007611 VS3007613 VS3007773 VS3007806 VS3007851 VS3008688 VS3008878 VS3005888 VS3006525 VS3006538 VS3006545 VS3006556 VS3006560 VS3006581 VS3006585 VS3006654 VS3006668 VS3006694 VS3007005 VS3007010 VS3007057 VS3007126 VS3007127 VS3007132 VS3007134 VS3007151 VS3007152 VS3006197 VS3006217 VS3006222 VS3007038 VS3007052 VSF5200060 VSF5200061 VSF5200063 VSF5200064 VSF5200065 VSF5200066 VSF5200067 VSF5200069 VSF5200071 VSF5200073 VSF5200074 VSF5200075 VSF5200076 VSF5200077 VSF5200078 VSF5200079 VSF5200080 VSF5200081 VSF5200082 VSF5200083 VSF5200084 VSF5200085 VSF5200086 VSF5200087 VSF5200088 VSF5200089 VSF5200091 VSF5200092 VSF5200093 VSF5200094 VSF5200095 VSF5200130 VSF5200192 VSF5200193 VSF5200196 VSF5200206 VSF5200229 VSF5200237 VSF5200254 VSF5200260 VSF5200261 VSF5200266 VSF5200268 VSF5200273 VSF5200274 VSF5200275 VSF5200278 VSF5200279 VSF5200280 VSF5200285 VSF5200287 VSF5200288 VSF5200289 VSF5200300 VSF5200309 VSF5200310 VSF5200323 VSF5200332 VSF5200334 VSF5200558 VSF5200562 VSF5200564 VSF5200565 VSF5200568 VSF5200828 VSF5200887 VSF5200894 VSF5200902 VSF5200903 VSF5200904 VSF5200905 VSF5200907 VSF5200911 VSF5200913 VSF5200928 VSF5200929 VSF5200930 VSF5200932 VSF5200934 VSF5200937 VSF5200942 VSF5200943 VSF5200944 VSF5200945 VSF5200946 VSF5200948 VSF5200950 VSF5200952 VSF5200953 VSF5200954 VSF5200955 VSF5200959 VSF5200960 VSF5200961 VSF5200962 VSF5200963 VSF5200964 VSF5200965 VSF5200966 VSF5200967 VSF5200968 VSF5200971 VSF5200973 VSF5200974 VSF5200975 VSF5200976 VSF5200977 VSF5200978 VSF5200985 VSF5200986 VSF5200987 VSF5200988 VSF5200989 VSF5200990 VSF5200991 VSF5200992 VSF5200994 VSF5201049 VSF5201056 VSF5201057 VSF5201066 VSF5201071 VSF5201075 VSF5201076 VSF5201079 VSF5201080 VSF5201082 VSF5201085 VSF5201086 VSF5201089 VSF5201093 VSF5201094 VSF5201095 VSF5201099 VSF5201100 VSF5201101 VSF5201105 VSF5201106 VSF5201108 VSF5201110 VSF5201111 VSF5201115 VSF5201116 VSF5201117 VSF5201118 VSF5202405 VSF5202416 VSF5202423 VSF5202437 VS3004618 VS3004668 VS3004986 VS3005762 VS3005804 VS3005816 VS3005817 VS3005822 VS3005908 VS3006190 VS3006215 VS3006529 VS3006552 VS3006666 VS3007012 VS3007014 VS3007145 VS3007168 VS3007221 VS3007274 VS3007299 VS3007413 VS3007439 VS3007507 VS3007582 VS3007753 VS3007866 VS3007880 VS3007893 VS3007898 VSF5200357 VSF5200360 VSF5200374 VSF5200378 VSF5200388 VSF5200412 VSF5200476 VSF5200481 VSF5200508 VSF5200527 VSF5200531 VSF5200532 VSF5200533 VS3004925 VS3007190 VS3007193 VS3007527 VS3007280 VS3007297 VS3007383 VS3007541 VS3007904 VS3008640 VS3008660 VS3008665 VS3008786 VS3008802 VS3008845 VS3008846 VS3008852 VSF5200090 VSF5200096 VSF5200097 VSF5200098 VSF5200099 VSF5200100 VSF5200101 VSF5200102 VSF5200103 VSF5200104 VSF5200105 VSF5200106 VSF5200107 VSF5200108 VSF5200109 VSF5200110 VSF5200111 VSF5200112 VSF5200113 VSF5200114 VSF5200115 VSF5200116 VSF5200118 VSF5200119 VSF5200121 VSF5200122 VSF5200126 VSF5200133 VSF5200218 VSF5200225 VSF5200231 VSF5200241 VSF5200258 VSF5200259 VSF5200262 VSF5200265 VSF5200270 VSF5200272 VSF5200281 VSF5200283 VSF5200284 VSF5200286 VSF5200290 VSF5200291 VSF5200304 VSF5200528 VSF5200539 VSF5200544 VSF5200550 VSF5200557 VSF5200573 VSF5200592 VSF5200593 VSF5200594 VSF5200595 VSF5200658 VSF5200659 VSF5200795 VSF5200806 VSF5200831 VSF5200834 VSF5200841 VSF5200843 VSF5200844 VSF5200845 VSF5200852 VSF5200853 VSF5200854 VSF5200856 VSF5200857 VSF5200862 VSF5200863 VSF5200864 VSF5200865 VSF5200866 VSF5200867 VSF5200868 VSF5200871 VSF5200873 VSF5200874 VSF5200875 VSF5200876 VSF5200881 VSF5200882 VSF5200883 VSF5200884 VSF5200885 VSF5200886 VSF5200895 VSF5200908 VSF5200909 VSF5200993 VSF5201002 VSF5201003 VSF5201005 VSF5201008 VSF5201010 VSF5201011 VSF5201012 VSF5201013 VSF5201014 VSF5201015 VSF5201017 VSF5201020 VSF5201024 VSF5201026 VSF5201027 VSF5201029 VSF5201030 VSF5201031 VSF5201032 VSF5201034 VSF5201035 VSF5201036 VSF5201037 VSF5201040 VSF5201043 VSF5201044 VSF5201045 VSF5201048 VSF5201050 VSF5201051 VSF5201055 VSF5201058 VSF5201059 VSF5201060 VSF5201061 VSF5201062 VSF5201063 VSF5201070 VSF5201072 VSF5201074 VSF5201077 VSF5201078 VSF5201081 VSF5201090 VSF5201091 VSF5201098 VSF5201121 VSF5201130 VSF5201131 VSF5201133 VSF5201134 VSF5201136 VSF5201137 VSF5201138 VSF5201143 VSF5201147 VSF5201148 VSF5201149 VSF5201150 VSF5201151 VSF5201152 VSF5201153 VSF5201154 VSF5201158 VSF5201159 VSF5201160 VSF5201161 VSF5201162 VSF5201163 VSF5201164 VSF5201165 VSF5201167 VSF5201168 VSF5201169 VSF5201170 VSF5201172 VSF5201175 VSF5201178 VSF5201180 VSF5201181 VSF5201182 VSF5201183 VSF5201184 VSF5201185 VSF5201186 VSF5201187 VSF5201188 VSF5201190 VSF5201191 VSF5201192 VSF5201195 VSF5201505 VSF5201522 VSF5201523 VSF5201530 VSF5201541 VSF5201545 VSF5201547 VSF5201750 VSF5201751 VSF5201758 VSF5202057 VSF5202116 VSF5202238 VSF5202248 VSF5202252 VSF5202255 VSF5202395 VS3005820 VS3005893 VS3005894 VS3005899 VS3005905 VS3005925 VS3005942 VS3007006 VS3007016 VS3007029 VS3007047 VS3007054 VS3007059 VS3007070 VS3007082 VS3007102 VS3007112 VS3007125 VS3007161 VS3007173 VS3007192 VS3007236 VS3007240 VS3007241 VS3007257 VS3007316 VS3007317 VS3007321 VS3007325 VS3007328 VS3007351 VS3007361 VS3007367 VS3007390 VS3007406 VS3007419 VS3007424 VS3007431 VS3007440 VS3007444 VS3007465 VS3007466 VS3007468 VS3007482 VS3007495 VS3007500 VS3007511 VS3007521 VS3007522 VS3007528 VS3007539 VS3007547 VS3007548 VS3007557 VS3007558 VS3007561 VS3007573 VS3007584 VS3007585 VS3007592 VS3007595 VS3007602 VS3007616 VS3007617 VS3007621 VS3007632 VS3007648 VS3007653 VS3007655 VS3007656 VS3007667 VS3007676 VS3007678 VS3007695 VS3007735 VS3007737 VS3007803 VS3007862 VS3007873 VS3007884 VS3007899 VS3007910 VS3007922 VS3008523 VS3008537 VS3008539 VS3008545 VS3008556 VS3008587 VS3008597 VS3008602 VS3008649 VS3008653 VS3008710 VS3008826 VS3008833 VS3008877 VS3008885 VS3008897 VS3008901 VS3008920 VS3008972 VS3008975 VS3004565 VS3004648 VS3004689 VS3004729 VS3004830 VS3004942 VS3004956 VS3004974 VS3004983 VS3005041 VS3005627 VS3005656 VS3005659 VS3005665 VS3005681 VS3005689 VS3005690 VS3005702 VS3005719 VS3005731 VS3005752 VS3005778 VS3005789 VS3005800 VS3005801 VS3005802 VS3005806 VS3005811 VS3005813 VS3005814 VS3005815 VS3005819 VS3005823 VS3005824 VS3005828 VS3005834 VSF5201240 VSF5201244 VSF5201257 VSF5201500 VSF5201501 VSF5201504 VSF5201506 VSF5201525 VSF5201569 VSF5202394 VS3007819 VS3008884 VS3004976 VS3005856 VS3006199 VS3006203 VS3007530 VSF5201260 VSF5201268 VS3005695 VS3005784 VS3005909 VS3006679 VS3007563 VS3008622 VS3006562 VS3007049 VS3007639 VS3007659 VSF5201550 VSF5201552 VSF5202104 VSF5202115 VS3007026 VS3005886 VS3007106 VS3007438 VS3006998 VS3007066 VS3007041 VS3007181 VS3007263 VS3007672 VS3007895 VSF5200326 VSF5201746 VS3005869 VS3007320 VS3007409 VS3007484 VS3007502 VS3007526 VSF5201193 VSF5201199 VSF5201201 VSF5201202 VSF5201203 VSF5201204 VSF5202055 VS3007324 VS3007556 VS3008912 VSF5202124 VS3005668 VS3005691 VS3007208 VS3008696 VS3008541 VSF5201595 VSF5201710 VSF5201974 VS3006555 VS3006559 VS3007301 VS3007630 VS3007638 VS3007670 VS3008942 VS3007501 VS3007717 VS3006550 VS3006566 VS3006643 VS3006650 VS3006652 VS3006657 VS3007024 VS3007204 VS3007206 VS3007272 VS3007305 VS3007508 VS3007600 VS3009019 VSF5200358 VSF5200414 VSF5200339 VSF5200347 VSF5200366 VSF5200367 VSF5200368 VSF5200370 VSF5200376 VSF5200377 VSF5200386 VSF5200387 VSF5200395 VSF5200397 VSF5200401 VSF5200416 VSF5200462 VSF5200464 VSF5200465 VSF5200467 VSF5200475 VSF5200480 VSF5200498 VS3008584 VS3007814
RECALLING FIRM/MANUFACTURER
Respironics California, Inc., Carlsbad, CA, by letter on August 8, 2006. Firm initiated recall is ongoing.
REASON
This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases, in which a fan also failed, have shown signs of fire damage.
VOLUME OF PRODUCT IN COMMERCE
950 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Favius GS Anesthesia Machine. Catalog number 8604699, Recall # Z-0048-2007.
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letters on October 3, 2006.
Manufacturer: Drager Medical AG & Co. KGAA, Luebeck, Germany. Firm initiated recall is ongoing.
REASON
One of four casters may break loose from chassis.
VOLUME OF PRODUCT IN COMMERCE
429 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
DynaRad Phantom Portable X-Ray System; Phantom model (PH-150-CM & PH-150-G), Recall # Z-0049-2007
CODE
Generator serial numbers: 03460-1003, 03477-1003, 03499-1003, 03550-1003, 03647-1003, 03704-1003, 03734-1003, 03744-1003, 03759-1003, 03765-1003, 03823-1003, 03938-1103, 03941-1103, 03953-1003, 04227-1103, 04282-1203, 04303-1203, 04330-1203, 04477-1203, 04497-1203, 04666-1203, 04704-1203, 00013-0104, 00035-0104, 00107-0104, 00122-0104, 00127-0104, 00188-0104, 00192-0104, 00332-0104, 00336-0104, 00405-0104, 00417-0104, 00430-0104, 00474-0104, 00545-0204, 00555-0204, 00568-0204, 00709-0204, 00719-0204, 00741-0204, 00754-0204, 00776-0204, 00995-0304, 00999-0304, 01101-0304, 01291-0304, 01295-0304, 01369-0304, 01423-0404, 01450-0404, 01468-0404, 01473-0404
RECALLING FIRM/MANUFACTURER
Del Medical Systems Group, Franklin Park, IL, by letters dated October 3, 2006. Firm initiated recall is ongoing.
REASON
The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide and Thailand

______________________________
PRODUCT
Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic), Recall # Z-0050-2007
CODE
Lot Numbers: CN04J012, CN 06A003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated August 1, 2006 and August 2, 2006.
Manufacturer: Centex Machining, Inc., Round Rock, TX. Firm initiated recall is ongoing.
REASON
Bone reamer may not have a cutting surface on the tip.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
AMPLATZER PFO Occluder. Order No. 9-PFO-018.
Device is not PMA approved in the US. 18mm Sterile EO.
MRI Compatible. The AMPLATZER PFO Occluder is a
self-expandable, double disc device made from a Nitinol
wire mesh, Recall # Z-0052-2007;
b) AMPLATZER PFO Occluder. Order No. 9-PFO-025.
Device is not PMA approved in the US. 25mm Sterile EO.
MRI Compatible. The AMPLATZER PFO Occluder is a
self-expandable, double disc device made from a Nitinol
wire mesh, Recall # Z-0053-2007
CODE
a) Lot number M06B01-52, serial numbers 190477 -- 190494;
b) Lot number M06B01-58, serial numbers 190495 - 190512
RECALLING FIRM/MANUFACTURER
AGA Medical Corporation, Golden Valley MN, by via fax and letter, dated June 1, 2006. Firm initiated recall is ongoing.
REASON
AMPLATZER PFO Occluders were mislabeled with incorrect device size. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Internationally

______________________________
PRODUCT
GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application), Recall # Z-0055-2007
CODE
Software version 3.8 and earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Healthcare, Wauwatosa, WI, by letter dated August 4, 2006.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur.
VOLUME OF PRODUCT IN COMMERCE
5,203 systems
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: DEVICES- - CLASS III

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PRODUCT
DeVilbiss iFill Personal Oxygen Station model number 535D, Recall # Z-0038-2007
CODE
Serial numbers AD01145 through AD01462
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Somerset, PA, by telephone on August 24, 2006 and by letter on August 28, 2006. Firm initiated recall is ongoing.
REASON
Potential for oxygen cylinders to not fill completely.
VOLUME OF PRODUCT IN COMMERCE
252 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, REF 60A 160, Recall # Z-0046-2007
CODE
Lots: 1037018 and 1045416
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Gary IN, by letter on August 11, 2006. Firm initiated recall is ongoing.
REASON
The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
VOLUME OF PRODUCT IN COMMERCE
71 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Stic Kit Needle Containment Device, Model EMI 82691, packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band, Recall # Z-0056-2007
CODE
Lot codes: 070505 and 110602
RECALLING FIRM/MANUFACTURER
Recalling Firm: EM Innovations, Inc. Galloway, OH, by telephone on April 3-5, 2006 and July 11, 2006.
Manufacturer: Enterprise Plastics, Kent, OH. Firm initiated recall is ongoing.
REASON
The firm failed to include User Instructions with the Stic Kit Needle Containment Device, when shipped.
VOLUME OF PRODUCT IN COMMERCE
2,462 devices
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR October 25, 2006

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