FDA

Enforcement Report

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

February 5, 1997 97-06

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Pepperidge Farm Snack Mixes:
(a) Pepperidge Farm Gold Fish Fat Free Pretzel
Mix, 9-1/4 ounces and 1.5 ounces;
(b) Pepperidge Farm Gold Fish Seasoned Snack
Mix, 9-1/4 ounces; (c) Pepperidge Farm Savory
Gold Fish Snack Mix, 32 ounces.
Recall #F-231/233-7.
CODE For product with net weight of 9 1/4 ounces,
all product manufactured on before 9/25/96
with an expiration date on or before 2/15/97.
For the product with net weight of 1.5 ounces,
all product with an expiration date on or
before 3/1/97. For product with net weight of
32 ounces, all product with expiration date on
or before 3/22/97.
MANUFACTURER Pepperidge Farm, Willard, Ohio.
RECALLED BY Pepperidge Farm, Norwalk, Connecticut, by
press release on November 22, 1996, and by fax
followed by telephone. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 388,416 cases (9-1/4 ounces) and 73,020
cases (1-1/2 ounces); (b) 433,704 cases;
(c) 68,190 cases were manufactured.
REASON The products may contain undeclared peanuts.

_______________
PRODUCT Candy Advent Calendar, "24 Day Christmas
Countdown". Recall #F-234-7.
CODE None.
MANUFACTURER Product of Poland.
RECALLED BY Morris National Company, Inc., Azusa,
California, by letter on December 12, 1996,
and by press release on December 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 150,000 consumer units were
distributed.
REASON Product contains undeclared peanut protein.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Aredia (Pamidronate Disodium) For Injection,
60 mg vials, Rx indicated for the treatment of
patients with moderate hypercalcemia
associated with malignancy in conjunction with
adequate hydration. Recall #D-087-7.
CODE Lot #1000500 EXP 3/97.
MANUFACTURER Ciba Pharmaceuticals, Summit, New Jersey.
RECALLED BY Manufacturer, by fax on May 10, 1996, followed
by letter sent on May 15, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 750 vials were distributed.
REASON Product label mix-up. Some unit carton labels
may show two different strengths, 90 mg and 60
mg (correct).

_______________
PRODUCT Sus-Phrine, Epinephrine Injectable Suspension,
5 mg/ml, in 0.3 ml ampules, Rx indicated for
use for the symptomatic treatment of bronchial
asthma, and reversible bronchospasm associated
with bronchitis and emphysema.
Recall #D-091-7.
CODE Lot numbers: 95A751 EXP 1/98 (10 per box),
95E030 EXP 5/98 (10 per box), 95E550 EXP 6/98
(25 per box).
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.

-2-RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri, by letter dated December 30, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,772 boxes were distributed.
REASON Some packages may be moldy.

_______________
PRODUCT Bristol Myers Squibb's OVCON35 - 28 Day
(Norethindrone and Ethinyl Estradiol Tablets,
USP), Rx oral contraceptive packaged as 28-day
regimen with 21 active ingredient tablets and
7 inactive (placebo) tablets in a blister
strip compact. Recall #D-096-7.
CODE Lot #H6J272A EXP 8/98.
MANUFACTURER Bristol Laboratories, Corporation, Mayaguez,
Puerto Rico.
RECALLED BY Bristol Myers Squibb Company, New Brunswick,
New Jersey, by letter dated January 15, 1997,
followed by a revised letter dated January 18,
1997, and by press release on January 17,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 25,056 cartons (6 compacts/carton) were
distributed.
REASON Contraceptive tablets are out of sequence (the
seven inactive tablets were mistakenly
packaged to be taken the first seven days of
the 28-day cycle instead of the last seven
days).

RECALLS AND FIELD CORRECTIONS: DRUGS --- CLASS III =========
_______________
PRODUCT Extra Strength Tylenol (Acetaminophen)
Gelcaps, 500 mg, in bottles of 50, 100, or
300, OTC pain reliever/fever reducer.
Recall #D-083-7.
CODE Lot numbers: SPA 664 (50s), SPA 745 (100s),
SPA 751 (300s).
MANUFACTURER McNeil Consumer Products Company, Las Piedras,
Puerto Rico.
RECALLED BY McNeil Consumer Products Company, Fort
Washington, Pennsylvania, by letter dated
December 27, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 339,912 bottles of lot SPA 664; 96,240 bottles
of lot SPA 745; 7,272 bottles of lot SPA 751
were distributed.
REASON Microbial contamination of non-sterile product
(gelatin coating exceeded internal
specification for aerobic microorganisms).
-3-_______________
PRODUCT Leucovorin Calcium Tablets, Rx oral derivative
of folic acid: (a) 5 mg; (b) 25 mg.
Recall #D-088/089-7.
CODE Lot numbers: 6B107, 6H428, 6S162.
MANUFACTURER Barr Laboratories, Inc., Northvale, New
Jersey.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois, by
letter dated January 2, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 2,614 unit cartons: (b) 180 unit cartons
were distributed; firm estimated that 40% of
the 5 mg and 75% of the 25 mg product remained
on market at time of recall initiation.
REASON The particle size range of the bulk active
ingredient is outside the normal range and
could cause the product to fail the content
uniformity test.

_______________
PRODUCT E-Z-EM brand Liquid Polibar, Barium Sulfate
Suspension, in 64 fluid ounce bottles, Rx
product for use as radiological contrast media
for upper and lower gastrointestinal
procedures by conventional x-ray or computed
tomography. Recall #D-090-7.
CODE Catalog Number L164, Lot numbers: 1B8687,
1B8688 and 1B8689 EXP 1/97.
MANUFACTURER Therapex, Division of E-Z-EM Canada, Inc.,
Quebec, Canada.
RECALLED BY E-Z-EM, Inc., Westbury, New York, by letter
mailed on December 30, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 367 cases of lot 1B8687; 402 cases of lot
1B8688, 318 cases of lot 1B8689 (4 bottles per
case) were distributed.
REASON Product is not stable (failed total solids and
barium content assays on stability).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-127-7.
CODE Unit #21FJ04987.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated July 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.
-4-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-278/280-7.
CODE Unit #355950.
MANUFACTURER Memorial Blood Centers of Minnesota,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letters dated May 9, 1996 and
June 3, 1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina, Florida, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within 12 months of
donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Single Donor Plasma; (f) Fresh Frozen Plasma,
for further manufacture; (g) Source
Leukocytes; (h) Recovered Plasma.
Recall #B-298/305-7.
CODE Unit numbers: (a) 9537728, 9633605, 8965252,
8980568, 9012160, 9027003, 9076560, 9137112,
9137513, 9185851, 9207443, 9342867, 9630976;
(b) 9633605, 8980568, 9012160, 9027003,
9692638, 9630976; (c) 8965252, 9038149,
9342867; (d) 9692638, 9630976; (e) 9692638;
(f) 8880628, 8934808, 8980568, 9012160,
9027003, 9076560, 9137112, 9137513, 9207443;
(g) 9185851; (h) 9407336, 9537919, 9630976.
MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter dated May 2, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Massachusetts, Kentucky, Indiana, Texas,
Illinois, Florida.
QUANTITY (a) 13 units; (b) 6 units; (c) 3 units; (d) 2
units; (e) 1 unit; (f) 9 units; (g) 1 unit;
(h) 3 units were distributed.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from donors who previously were
confirmed positive for HBsAg.

_______________
PRODUCT Source Plasma. Recall #B-307-7.
CODE Unit #65211151.
MANUFACTURER Simi Biological Resources, Inc., Tacoma,
Washington.
RECALLED BY Manufacturer, by letter dated May 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.

-5-QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of high risk behavior.

______________
PRODUCT Source Plasma. Recall #B-308-7.
CODE Unit numbers: 58526811, 58528228, 59008552,
59009740.
MANUFACTURER Simi Biological Resources, Inc., Fort Smith,
Arkansas.
RECALLED BY Manufacturer, by letter dated January 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products were collected from a donor who
reported a history of high risk behavior.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-309/310-7.
CODE Unit #28LQ10807.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer, by telephone on September 27,
1996. Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit of each component.
REASON Blood products, corresponding to a unit of
Platelets which was positive for coagulase
negative Staphylococcus, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-314/315-7.
CODE Unit #32KF06807.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated March 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-317/320-7.
CODE Unit numbers: (a) 32G82080, 32G96920,
32H96969, 32H38140, 32H21662; (b) 32G82080,
32G96920, 32H96969, 32H38140; (c) 32H38140;
(d) 32G82080, 32G96920, 32H96969, 32H21662.

-6-MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letters dated October 23,
1995 or November 8, 1995, or by fax in
February 1995. Firm-initiated recall
complete.
DISTRIBUTION Wisconsin, California, New York.
QUANTITY (a) 5 units; (b) 4 units; (c) 1 unit; (d) 4
units were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), were collected from
donors who previously tested repeatedly
reactive for anti-HIV-1.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-321/322-7.
CODE Unit numbers: 32T07129 and 32T07981.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letters dated December 28,
1994, and by fax on December 30, 1994. Firm-
initiated recall complete.
DISTRIBUTION Iowa and California.
QUANTITY 2 units of each component were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
indeterminate.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets;
(c) Recovered Plasma. Recall #B-327/329-7.
CODE Unit #2430544.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, New Jersey, Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within 12 months of
donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Recovered Plasma. Recall #B-330/332-7.
CODE Unit numbers: (a&c) 51J17595;
(a&b) 51F02583.

-7-MANUFACTURER American Red Cross Blood Services, Wichita,
Falls, Texas.
RECALLED BY Manufacturer, by letters dated November 3 and
6, 1995, and December 18, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas, California, Oklahoma.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit was
distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), but were subjected
to additional retesting.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-109-7.
CODE 21GF72818, 21GF72831, 21GF72924, 21GF72925,
21GF73026.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated April 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington state, Oregon.
QUANTITY 5 units were distributed.
REASON Blood products were not refrigerated within
eight hours of collection.

_______________
PRODUCT Whole Blood. Recall #B-295-7.
CODE Unit #32V23921.
MANUFACTURER American Red Cross Blood Services, Green Bay,
Wisconsin.
RECALLED BY Manufacturer, by telephone on September 6,
1995. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-296/297-7.
CODE Unit #29133-0975.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letters dated August 29,
1996, and October 28, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.

-8-REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc) were collected from a donor who
previously tested repeatedly reactive for anti
HBc.

_______________
PRODUCT Whole Blood. Recall #B-306-7.
CODE Unit #33LL21501.
MANUFACTURER American Red Cross Blood Services, Farmington,
Connecticut.
RECALLED BY Manufacturer, by letter dated September 13,
1995. Firm-initiated recall complete.
DISTRIBUTION Connecticut.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-311/313-7.
CODE Unit #53M03313.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated January 29,
1996, and November 26, 1996. Firm-initiated
recall complete.
DISTRIBUTION Maryland, Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested reactive for anti-
HIV-1, Western blot negative. The donor has
since met reentry.

_______________
PRODUCT Recovered Plasma. Recall #B-316-7.
CODE Unit #32KF06807.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by fax on March 12, 1996. Firm-
initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.

-9-RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT MinXray Mobile/Portable General Purpose
Podiatry Systems, used in general purpose
radiographic studies: (a) Model No. PM200
Mobile/Portable Podiatry Systems manufactured
before August 9, 1993, but introduced into
commerce outside the date of limitations
specified by Variance No. 94V-0003;
(b) Model No. PW200 Mobile/Portable Podiatry
Systems manufactured before August 9, 1993,
but introduced into commerce outside the date
of limitations specified by Variance No.
94V-0003. Recall #Z-015/016-7.
CODE Units manufactured prior to August 9, 1993,
but shipped subsequent to that date in
violation of Variance No. 94V-0003 Model
PM200: tubehead s/n 16645, 16646, 16648,
16649, 16651 Model PW200: tubehead s/n 16650.
MANUFACTURER Mikasa X-ray Co. Ltd., Tokyo, Japan.
RECALLED BY MinXray, Inc., Northbrook, Illinois. FDA
approved the firm's corrective action plan
October 22, 1996, and by end user notification
letters sent on January 15, 1997. Firm-
initiated field correction ongoing.
DISTRIBUTION New Jersey, New York, Pennsylvania, Indiana,
Ohio.
QUANTITY 6 units.
REASON The diagnostic x-ray devices failed to comply
with the Federal Performance Standard for
Diagnostic X-Ray Systems and their major
components for light illuminance and failed
the edge contrast ratio required.

_______________
PRODUCT VSI Sigmoidoscope Endosheaths, (sterile,
single use): (a) SS-V32 EndoSheath for use
with the S-V100 Video Sigmoidoscope, Catalog
No. 06-7101; (b) SS-F32 EndoSheath for use
with the S-F100 Fiber Optic Sigmoidoscope,
Catalog No. 06-2101. Recall #Z-199/200-7.
CODE Product shipped prior to 11/12/96.
MANUFACTURER Vision Sciences, Inc., Natick, Massachusetts.
RECALLED BY Manufacturer, by letter dated November 14,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,568 units were distributed.
REASON Hairline cracks were found at the corners of
the tray under the sealing flange, therefore
compromising the sterility of the devices.

-10-_______________
PRODUCT Undercover 1,000 cc Urine Collection Bag (The
Original Belly Bag). Recall #Z-203-7.
CODE Catalog #B-1000, Lot #A-8640.
MANUFACTURER North American Medical, Inc., Lubbock, Texas.
RECALLED BY Manufacturer, by letter dated November 21,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,860 units were distributed.
REASON An inadequate seal was found on the device
packaging, therefore compromising the
sterility of the device.

_______________
PRODUCT Olympus Remote Switch Model No. MH-965,
designed to be connected to the Olympus Camera
Control Unit OTV-S5C, and used in combination
with any OTV-S5 System Camera Heads or an OES
Laparo-Thoraco Videoscope. This provides the
endoscopist fingertip control of the VTR
operation or shutter release for still
photography using the EVIS Monitor Photo unit
SCV-3 or the Olympus Color Video Printer OEP.
Recall #Z-234-7.
CODE All lots.
MANUFACTURER Olympus Japan, Inc., Shirakawa, Japan.
RECALLED BY Olympus America, Inc., Melville, New York, by
letter dated October 30, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, Texas, Maryland, Florida, Georgia,
California, Illinois, Michigan, Oregon,
Pennsylvania.
QUANTITY 94 switches were distributed.
REASON The Color Bars are inadvertently displayed on
the monitor screen, when the MH-965 remote
switch for the OTV-S5 is used in conjunction
with an active cord from an unipolar
accessory.

_______________
PRODUCT Quinton Instrument Stress Test Monitors:
(a) Model No. Q3000 Monitor;
(b) Model No. Q4000 Monitor;
(c) Model No. Q4000K Monitor.
Recall #Z-235/237-7.
CODE All serial numbers.
MANUFACTURER Quinton Instrument Company, Bothell,
Washington.
RECALLED BY Manufacturer, by letter beginning on January
10, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 3,196 units; (b) 2,079 units; (c) 1,682
units were distributed.
-11-REASON A software anomaly could cause their
treadmills to erroneously increase or decrease
in speed, and/or grade when the "Stop EXER"
key is pressed at the end of a stage.

_______________
PRODUCT Neisseria Meningitides Polyvalent (Group A-D)
Agglutinating Serum, in-vitro diagnostic test
kit which consists of one 2 ml vial of
product. Recall #Z-239-7.
CODE Product Code ZM33, Lots K442010*, K262110,
K846210, K255210* (*only distributed in United
States.)
MANUFACTURER Murex Biotech, Ltd., Temple Hill, Dartford,
England.
RECALLED BY Murex Diagnostic, Inc., Norcross, Georgia, by
telephone, followed by letter dated April 3,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 28 kits were distributed
REASON The subject lots will not detect N.
meningitides Group B, due to activity
deterioration.

_______________
UPDATE Kangaroo Entriflush Enteral Feeding Pump,
Catalog #8884-352405 and #8884-352413,
manufactured by Sherwood Davis & Geck, which
appeared in the January 29, 1997, Enforcement
Report should read:
CODE: All pumps distributed between November
1, 1995 and November 22, 1996.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Ferris PolyMem Membrane Dressing, 3" x 3"
Sterile Pad, a non-adhesive sterile wound
dressing. Recall #Z-238-7.
CODE Product #5033, Lot #27696E1.
MANUFACTURER Ferris Manufacturing Corporation, Burr Ridge,
Illinois.
RECALLED BY Manufacturer, by letter dated November 12,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and The Netherlands.
QUANTITY 62 cases were distributed.
REASON Some of the pouches were mislabeled as,
"Ferris PolyMem 2" x 3" dressings with
transparent adhesive film borders, Product No.
405".

-12-RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ========
_______________
PRODUCT Veterinary Chorionic Gonadotropin for
Injection, USP, 10,000 units per sterile 10 ml
multiple dose monovial, under the Steris
Laboratories and The Butler Company labels.
Recall #V-026-7.
CODE Codes: Lot numbers: 94C050, 94D160, 94L470,
95D640, 95F100, 95G570, 95H930, 97J230.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona
RECALLED BY Manufacturer, by letter dated May 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 34,000 vials were distributed.
REASON Silicon particulate matter in vials.

_______________
PRODUCT Veterinary vitamin injectable "B" Complex with
C and B12 Injection, (10 mL multiple dose
monovial), under Steris Laboratories, A & G
Pharmaceuticals and The Butler Company labels.
Recall #V-027-7.
CODE Lot numbers: 93K090, 93K360, 94A320, 94B470,
94C240, 94E080, 94J370, 94K430, 94L560,
95A310, 95A430, 95A820, 95B660, 95B970,
95C860, 95E540, 95G700, 95G890.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter dated April 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 31,500 vials were distributed.
REASON Stability data does not support labeled
expiration dates.

-13-

END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for