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U.S. Department of Health and Human Services

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Enforcement Report for July 7, 2004

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.


July 7, 2004
04-27

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Garoye brand Lily Flower, Net Wt. 6 oz., Product of China. Recall # F-273-4.
CODE
Barcode # 922344 500029 and no other coding.
RECALLING FIRM/MANUFACTURER
Hop Lee Trading Co., Inc., Brooklyn, NY, by press release and telephone on May 14, 2004. New York State initiated recall is complete.
REASON
Product contains undeclared sulfites (3340 ppm) based on sampling & analysis by New York State Department of Agriculture and Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
42 ? 6 oz. packages.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Hammons Pantry Whole Almonds, packaged in 8 oz. and 16 oz. clear cellophane bags and 5 lb. boxes identified as HB-30 Whole Almonds. Recall # F-274-4.
CODE
Product purchased between October 2, 2003 and May 25, 2004.
RECALLING FIRM/MANUFACTURER
Hammons Products Co., Stockton, MO, by telephone on May 26, 2004, and by press release and letters dated May 27, 2004. FDA initiated recall is ongoing.
REASON
The product is associated with Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
478 lbs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Butter Almond Ice Cream, packed into a 3 gallon plastic bucket with a plastic lid. Recall # F-275-4.
CODE
?EXP DATE DEC 2004? and all earlier expiration dates.
RECALLING FIRM/MANUFACTURER
Valentine Italian Specialties, Miami, FL, by telephone on June 3, 2004 and by letter on June 4, 2004. Firm initiated recall is complete.
REASON
The product contains almonds that are associated with Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
8 ? 3 gallon containers.
DISTRIBUTION
FL.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Phenytoin Oral Suspension USP (125MG/5ML), 8 oz bottles (237mL), Rx only, NDC #0472-0067-08. Recall # D-209-4.
CODE
Lot Number Expiration Date RP2715 EXP 09/04 RS2744 EXP 10/04 RS2745 EXP 11/04 RA3036 EXP 11/04 RA3037 EXP 11/04 RA3038 EXP 11/04 RA3039 EXP 11/04 RB3089 EXP 12/04 RB3090 EXP 12/04 RD3159 EXP 01/05 RD3160 EXP 01/05 RD3161 EXP 01/05 RF3211 EXP 02/05 RF3212 EXP 02/05 RH3263 EXP 02/05 RH3264 EXP 02/05 RH3265 EXP 03/05 RH3266 EXP 03/05 RL3407 EXP 04/05 QL3478 EXP 04/05 QL3479 EXP 04/05 QL 3480 EXP 04/05.
RECALLING FIRM/MANUFACTURER
Alpharma USPD, Baltimore, MD, by letter on April 26, 2004. Firm initiated recall is ongoing.
REASON
Product not manufactured as per approved method (additional unapproved mixing).
VOLUME OF PRODUCT IN COMMERCE
317,952 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Cortisporin -TC Otic Suspension, Each mL contains: (Colistin sulfate equivalent to 3mg of colistin base activity, Neomycin sulfate equivalent to 3.3mg neomycin base activity, Hydrocortisone acetate 10mg (1%), Thonzonium bromide 0.5mg (0.05%)), 10 mL bottle with dropper, Rx Only, Sterile, NDC 61570-090-10. Recall # D-210-4.
CODE
Lot Number: 00433M, Expiration: 07/04.
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals, Inc., Bristol, TN, by letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; product cap may not have been adequately tightened when assembled to bottle.
VOLUME OF PRODUCT IN COMMERCE
26,991 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
a) M.T.E.-4 Mixture of Four Trace Elements Additive, Preservative Free, Each
mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg and Chromium 4
mcg), 3 mL and 10 mL single dose vials, Rx only, For IV Use Only After
Dilution, NDC 63323-081-03 (3 mL) and NDC 63323-081-10 (10 mL).
Recall # D-197-4;
b) M.T.E.-4 Mixture of Four Trace Elements Additive, Each mL providing (Zinc
1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg), 30 mL multidose
vials, Rx only, For IV Use Only After Dilution, 60173; NDC 63323-087-30.
Recall # D-198-4;
c) M.T.E.-4 Concentrated Mixture of Four Trace Elements Additive,
Preservative Free, Each mL providing (Zinc 5 mg, Copper 1 mg, Manganese
0.5 mg and Chromium 10 mcg), 1 mL single dose vials, Rx only, For IV Use
Only After Dilution; NDC 63323-094-01. Recall # D-199-4;
d) M.T.E.-4 Concentrated, Mixture of Four Trace Elements Additive, Each mL
providing (Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg), 10
mL multidose vials, Rx only, For IV Use Only After Dilution; NDC 63323-
098-10. Recall # D-200-4;
e) M.T.E.-5 Mixture of Five Trace Elements Additive, Preservative Free, Each
mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg
and Selenium 20 mcg), 10 mL single dose vials, Rx only, Must be diluted
before IV use; NDC 63323-018-10. Recall # D-201-4;
f) M.T.E.-5 Concentrated, Mixture of Five Trace Elements Additive, Each mL
providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, chromium 4 mcg,
Selenium 20 mcg), 10 mL multidose vials, Rx only, Must be diluted before
IV use, NDC 63323-029-10. Recall # D-202-4;
g) M.T.E.-6 Mixture of Six Trace Elements Additive, Preservative Free, Each
mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg,
Selenium 20 mcg and Iodide 25 mcg), 10 mL single dose vials, Rx only,
Must be diluted before IV use, NDC 63323-020-10. Recall # D-203-4;
h) M.T.E.-7 Mixture of Seven Trace Elements Additive, Preservative Free,
Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4
mcg, Selenium 20 mcg, Iodide 25 mcg and Molybdenum 25 mcg),10 mL single
dose vials, Rx only, Must be diluted before IV use; NDC 63323-014-10.
Recall # D-204-4;
i) Neotrace-4 Neonatal Mixture of Four Trace Elements Additive, Preservative
Free Eac, Each mL providing (Zinc 1.5 mg, Copper 0.1 mg, Manganese 25 mcg
and Chromium 0.85 mcg) 2 mL single dose vials, Rx only, For IV use only
after dilution; NDC 63323-141-02. Recall # D-205-4;
j) Pedtrace-4 Pediatric Mixture of Four Trace Elements Additive,
Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.1 mg, Manganese
25 mcg and Chromium 1 mcg), 10 mL single dose vials, Rx only, For IV use
only after dilution; NDC 63323-138-10. Recall # D-206-4;
k) P.T.E.-4 Pediatric Mixture of Four Trace Elements Additive, Preservative
Free, Each mL providing (Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and
Chromium 1mcg) 3 mL single dose vials, Rx only, For IV use only after
dilution, NDC 63323-082-03. Recall # D-207-4;
l) P.T.E.-5 Pediatric Mixture of Five Trace Elements Additive, Preservative
Free, Each mL providing (Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg,
Chromium 1mcg and Selenium 15 mcg), 3 mL single dose vials, Rx only, For
IV use only after dilution, NDC 63323-144-03. Recall # D-208-4.
CODE
a) 3 mL vials: Lot 111193, exp. 12/31/04; Lot 120643, exp. 05/31/05;
Lot 121426, exp. 12/31/05; 10 mL vials: Lot 111107, exp. 11/30/04;
Lot 120593, exp. 05/31/05; Lot 121265, exp. 10/31/05;
b) Lot 111252, exp. 12/31/04; Lot 120605, exp. 5/31/05; Lot 130232, exp.
03/31/06;
c) Lot 121225, exp. 10/31/04;
d) Lot 111241, exp. 12/31/04;
e) Lot 120604, exp. 05/31/04; Lot 121034, exp. 08/31/04;
f) Lot 111135, exp. 11/30/04;
g) Lot 120762, exp. 06/30/04;
h) Lot 120586, exp. 05/31/04;
i) Lot 111250, exp. 06/30/04; Lot 120615, exp. 11/30/04; Lot 121088, exp.
03/31/05; Lot 130300, exp. 09/30/05;
j) Lot 120763, exp. 06/30/04; Lot 130497, exp. 05/31/05;
k) Lot 120730, exp. 06/30/04;
l) Lot 120413, exp. 10/31/04; Lot 120819, exp. 01/31/05; Lot 130288, exp.
09/30/05.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letter dated May 27, 2004. Firm initiated recall is ongoing.
REASON
Stability; lack of assurance that product potency will be maintained through labeled expiration.
VOLUME OF PRODUCT IN COMMERCE
2,128,940 vials.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-1552-4.
CODE
Units 67794836, 67790791, 67787111, 67782895, 67779048, 67755479, 67738946, 67728664, 67716500, 67698554, 67694884, 67690466, 67678457, 67670413, 67655441, 67651924, 51811921, 51807443, 51804039, 51800383, 51797058.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by facsimile on June 28, 2002.
Manufacturing Firm:   Plasma Biological Services, Inc., Johnson City, TN. Firm initiated recall is complete.
REASON
Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1553-4.
CODE
Unit number FW41677.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc. Milwaukee, WI, by telephone on October 31, 2002, and by letter on November 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1554-4.
CODE
Unit number 17FJ21332.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter on October 17, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1555-4.
CODE
Unit number 49GR60806.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letters on July 1, 2002, August 20, 2002, and September 6, 2002. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1560-4.
CODE
Unit number 49LW09869.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letters on May 14, 2002 and 24, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+. Recall #
Z-0985-04;
b) MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and
PW200R40 (wall mounted). Recall # Z-0986-04.
CODE
a) Serial numbers 24371, 24372, 24374, 24375, 24376, 24377, 24379, 24380,
24495, 24496, 24497, 24498, 24499, 24500, 24501, 24502, 24503, 24504,
24505, 24506, 24507, 24508, 25560, 25561, 25562, 25564, 25566, 25567,
25568, 25569, 25570S, 25572, 25573, 25574, 25575, 25576, 25577, 25578,
25579, 25580, 25581, 25582, 25583, 25584S, 25585, 25586, 25587, 25588,
25589;
b) Model PM200R40: serial numbers 23528M, 23531M, 23533M, 23534M, 23535M,
23536M, 24360M, 24361M, 24363M, 24364M, 24365M, 24368M, 24369M, 25148M,
25149, 25390M, 25391M, 25392M, 25393M, 25394M, 25395M, 25396M, 25397M,
25400M, 25402M, 25403M, 25404M, 25405M, 25406M, 25407M, 25408, 26500M,
26501, 26502, 26503M, 26504M, 26505, 26506, 26508, 26509, 26510, 26511,
26512, 26513M, 26514, 26515, 26516, 26517, 26518, 26519 Model PW200R40,
serial numbers 23530, 23538, 24362W, 24367W, 24369W, 25399W.
RECALLING FIRM/MANUFACTURER
Minxray, Inc., Northbrook, IL, by letters dated June 29, 2004. FDA initiated recall is ongoing.
REASON
The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
VOLUME OF PRODUCT IN COMMERCE
105 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Ant-Cer Dynamic Cervical Plating System Literature. Recall # Z-1038-04.
CODE
All literature.
RECALLING FIRM/MANUFACTURER
Spinal Concepts, Inc., Austin, TX, by letter beginning March 9, 2004. Firm initiated recall is ongoing.
REASON
Recall of product literature that describes use of the device. Product literature implies that the plates ratchet mechanism is capable of preventing off-loading of the graft in extension. While the ratchet may offer some resistance in extension, it is neither intended to prevent off-loading of the graft nor disassociation of the plates. The two functions of the ratchet are to keep the plates in position during surgery and to allow the surgeon to set the desired amount of setting by the plate.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003. Recall # Z-1039-04.
CODE
Lot number 6234, EXP 10/20/04.
RECALLING FIRM/MANUFACTURER
Digene Corp, Gaithersburg, MD, by telephone on May 28, 2004, and by letter on June 2, 2004. Firm initiated recall is ongoing.
REASON
In vitro diagnostic test kit may produce false negative clinical results.
VOLUME OF PRODUCT IN COMMERCE
206 kits.
DISTRIBUTION
Nationwide and the United Kingdom.

_______________________________
PRODUCT
Synchromed II infusion pump. Recall # Z-1040-04.
CODE
Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by letter on May 11, 2004. Firm initiated recall is ongoing.
REASON
The opposite version serial numbers are assigned to 20 mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Recall # Z-1044-04.
CODE
Catalog Number: 001-1-110: Lot numbers.31005619, 040307981, 031105860, 040106663 Catalog Number: 001-1-320: Lot Numbers: 040308006, 040106665, 040307894, 031005622, 031105863, Catalog Number: 001-1-120: Lot Numbers: 040106664, 040307892, 040307982, Catalog Number: 001-1-140: Lot Number: 031065620 Catalog Number: 001-1-310: Lot Numbers: 031005621, 031105862, 040106667, 040307893, 040308005 Catalog Number: 001-1-330: Lot Numbers: 040106666, 040307895, 040308044.
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX, by letter on June 22, 2004. Firm initiated recall is ongoing.
REASON
Inadequate closure compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
5,604 units.
DISTRIBUTION
Nationwide and Japan.

_______________________________
PRODUCT
Magnetic Resonance Imaging System(s) Visart and Exelart P2/Exelart P3/Exelart SPIN and Exelart VANTAGE. Recall # Z-1045-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc., Tustin, CA, by letter on May 26, 2004. Firm initiated recall is ongoing.
REASON
Wrong positioning may cause patient burns.
VOLUME OF PRODUCT IN COMMERCE
58 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088. Recall # Z-1035-04.
CODE
Lot: 1215.
RECALLING FIRM/MANUFACTURER
The Straumann Co, Waltham, MA, by letter on May 21, 2004. Firm initiated recall is ongoing.
REASON
Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN).
VOLUME OF PRODUCT IN COMMERCE
23 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Advance? Medical's, The Closed Camera System, 9" x 96" (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile. Recall # Z-1036-04. Recall # Z-1036-04.
CODE
Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154.
RECALLING FIRM/MANUFACTURER
Advance Medical Designs, Inc., Marietta, GA, by telephone on June 17, 2004, and by letter on June 18, 2004. Firm initiated recall is ongoing.
REASON
The product may come apart when excessive force is applied to the coupler.
VOLUME OF PRODUCT IN COMMERCE
2340 units, *amended to include additional 250 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Staar Surgical Intra Occular Lens, Collamer. Recall # Z-1037-04.
CODE
All lenses packaged weeks of February 9-13 and 23-27.
RECALLING FIRM/MANUFACTURER
Staar Surgical Co., Inc., Monrovia, CA, by letter, onJune 17, 2004. Firm initiated recall is ongoing.
REASON
Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
VOLUME OF PRODUCT IN COMMERCE
Not specified.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic;
product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and
product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Recall
# Z-1041-04;
b) Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was
packaged under the following sizes:
a.1) Ortho-Jet Powder, product code 1320, 100 g plastic squeeze bottle;
a.2) Biocryl Resin Acrylic, product code 040-016, 1 lb. lab pack with
empty plastic squeeze bottle;
b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product CODE
1520, 100 g plastic squeeze bottle;
b.2) Contemporary Colored Assorted Kit, product code 045-088, 2 oz.
plastic squeeze bottles, 6 bottles per kit;
c.1) Electric Colored Ortho-Jet Powder, product code 2720, 100 g plastic
squeeze botles and product code 2793, 45 g plastic squeeze bottles/6
per kit;
c.2) Tropical Tones Acrylic Resin, product code 045-052, 4 oz. plastic
squeeze bottle. Recall # Z-1042-04;
c) Jet Denture Repair Acryulic, fast curing denture repair resin; PRODUCT
code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram
plastic squeeze bottle, professional package. Recall # Z-1043-04.
CODE
a) 2 oz. bottles: box lot 1410-4117, bottle lot 60074003/04AD - shade 62;
box lot 1410-4120, bottle lot 60044001/01AE - shade 59; box lot 1410-
4122, bottle lot 60123005/03AF - shade 69; 4 oz. bottles: box lot 1420-
4118, bottle lot 60083006/04AK - shade 65; box lot 1420-4119, bottle lot
60024001/01AJ - shade LI; box lot 1420-4120, bottle lot 60133003/03AJ ?
shade 77; box lot 1420-4123, bottle lot 60143005/03AK - shade 81; box lot
1420-4126, bottle lot 60103002/02AD - shade 67; box lot 1420-4128, bottle
lot 60024001/01AL - shade LI; box lot 1420-4130, bottle lot 60063002/02AU
shade 61; box lot 1420-4131, bottle lot 60074003/04AE - shade 62; box
lot 1420-4134, bottle lot 60173001/01BU - shade C4; box lot 1420-4135, bottle lot 60084001/01AC - shade 65;
b) a.1) product code 1320, box lot 1320-4005, bottle lot 60274005/04AB;
a.2) product code 040-016, lot 53-1334-4016, empty bottle and cap only;
b.1) product code 1520, box lot 1520-4020, bottle lot 15144002/01AB ?
Blue; box lot 1520-4023, bottle lot 15244006/01AH - White;
b.2) product code 045-088, box lot 53-1593-4006, bottle lots
15224001/01AQ - red, 15203002/01BS - orange, 15144002/01AA ? blue
and 15124003/01AP - black, and box lot 53-1593-4007, bottle lots
15124003/01AQ - black, 15144002/01AC - blue, 15203002/01BU - orange,
15224001/01AT - red, 15244006/01AF - white, 15263001/01CD - yellow;
c.1) product code 2720, box lot lot 2720-4021, bottle lot 60374001/01AH ?
pink; box lot 2720-4022, bottle lot 60363002/01BE -yellow; box lot
2720-4023, bottle lot 60374001/01AK - pink; product code 2793, kit
box lot 2793-4005, bottle lots 60343002/02AF - green, 27124001/01AF
- orange, 60374001/01AJ - pink, 27164001/01AS - red, 60363002/01BD ?
yellow and 60353005/01AS - blue;
c.2) product 045-052, box lot 53-2720-4044, bottle lot 60343002/02AE ?
key lime green;
c) Product code 1220, box lot 1220-4023, bottle lot 60274005/04AB - clear;
product code 1223, box lot 1223-4024, bottle lot 60274005/04AB -clear and
box lot 1223-4025, bottle lot 12163001/01AN - meharry.
RECALLING FIRM/MANUFACTURER
Lang Dental Mfg., Co., Inc., Wheeling, IL, by letters dated June 7, 2004 and June 14, 2004. Firm initiated recall is ongoing.
REASON
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
VOLUME OF PRODUCT IN COMMERCE
474 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR JULY 7, 2004

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