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.
ENFORCE
03/01/1995
Recalls and Field Corrections: Foods -- Class III -- 03/01/1995
March 1, 1995 95-9
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Oral Water Nursette 3 ounce glass bottles. Recall #F-476-5.
CODE MHD35 List #087-0268-45 EXP 3/1/96.
MANUFACTURER Bristol-Myers Squibb, Evansville, Indiana.
RECALLED BY Manufacturer, by letter or telephone November 23, 1994, and
by memorandum November 29, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 1,711 cases (48 bottles per case) were distributed.
REASON Product is contaminated with chlorine.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Medical Gas, in cylinder labeled in part helium USP 80%
Oxygen USP 20%. Recall #D-078-5.
CODE 95 032 Lot # CUFT EXP 2 2000.
MANUFACTURER Cascade Airgas, Inc., doing business as Welders Supply
Company, Seattle, Washington.
RECALLED BY Manufacturer, by telephone on or about February 2, 1995.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 20 cylinders.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Oxygen USP, a compressed medical gas, in size E cylinders.
Recall #D-069-5.
CODE Lot #173A520 EXP 20 JAN 2000.
MANUFACTURER Keen Compressed Gas, New Castle, Delaware.
RECALLED BY Manufacturer, by letter January 26, 1995. Firm-initiated
recall complete.
DISTRIBUTION Delaware, Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON Some cylinders were underfilled.
_______________
PRODUCT Cardizem-SR (diltiazem HCl) 90 mg Sustained Release
Capsules, 100 capsules per bottle, Rx for the treatment of
hypertension. Recall #D-070-5.
CODE Lot #P10264 EXP 9/9/95.
MANUFACTURER Elan Corporation. Plc., Athlone, County Westmeath, Ireland.
RECALLED BY Marion Merrell Dow, Inc., Kansas City, Missouri, by letter
February 8, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide(?).
QUANTITY 19,529 bottles were distributed.
REASON Product is marginally below the dissolution specification at
the 3 hour test.
_______________
PRODUCT Betamethasone Valerate USP 0.1 Ointment, in 15 and 45 gram
tubes, a topical corticosteroid with anti-inflammatory,
anti-pruritic and vasoconstrictive actions, under the
following labels: NMC, Goldline, Rugby, Major Quality,
Schein, H.L. Moore. Recall #D-071-5.
CODE Lot #2H806 EXP 2/95 (NMC, Goldline)
Lot #2L969 EXP 6/95 (NMC, Goldline, Major Quality, Schein)
Lot #3B101 EXP 8/95 (NMC, Goldline, Major Quality)
Lot #3C170 EXP 9/95 (NMC, H. L. Moore, Major Quality,
Rugby, Goldline, Schein)
Lot #3D237 EXP 10/95 (Goldline, Schein, NMC, Major
Quality)
Lot #3E288 EXP 11/95 (NMC, Goldline, Rugby, H. L.
Moore, Schein)
Lot #3F369 EXP 12/95 (NMC, Rugby, Goldline, Major Quality)
Lot #3F374 EXP 12/95 (NMC, Rugby, Major Quality, Schein)
Lot #3G441 exp. date 1/96 (NMC, Rugby, Major Quality, H. L.
Moore, Schein)
Lot #3J368 EXP 4/96 (NMC, H. L. Moore, Goldline Labs.
MANUFACTURER NMC Laboratories, Inc., Glendale, New York.
RECALLED BY Manufacturer, by letter February 9, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 215,112 45-gram tubes and 95,660 15-gram tubes were
distributed.
REASON Potency not assured through expiration date.
-2- _______________
PRODUCT PanMist S (Pseudoephedrine HCl, 45 mg, and Guaifenesin, 200
mg), an OTC decongestant, in 16 ounce and 15 ml bottles,
under the Pan American Laboratories label.
Recall #D-072-5.
CODE SG403SU, SG404SU, SG405SU, SG406SU, SI407SU, SI408SU,
SI409SU.
MANUFACTURER Sage Pharmaceuticals, Inc., Shreveport, Louisiana.
RECALLED BY Manufacturer, letter February 6, 1995. Firm-initiated
recall complete.
DISTRIBUTION Louisiana.
QUANTITY 42,055 bottles were returned.
REASON Precipitation of the Guaifenesin ingredient.
_______________
PRODUCT Baker Norton brand Verapamil Tablets, 180 mg, in bottles of
100, a coronary vasodilator. Recall #D-073-5.
CODE Lot #4K07321.
MANUFACTURER Baker Norton Pharmaceuticals, Miami, Florida.
RECALLED BY Manufacturer, by telephone followed by letter December 30,
1994. Firm-initiated field correction complete.
DISTRIBUTION Georgia, California, Arkansas, Maryland, Indiana, Tennessee.
QUANTITY 16,432 bottles or 759 shipper cases were distributed; firm
estimates none remains on the market.
REASON Some shipping cases were mislabeled as 240 mg strength
instead of 180 mg. The bottles are labeled correctly.
_______________
PRODUCT Top Care Isopropyl Rubbing Alcohol 70% USP, in 16 fluid
ounce bottles. Recall #D-074-5.
CODE Lot #2481 EXP 8/97.
MANUFACTURER Diamond Products, Seffner, Florida.
RECALLED BY Manufacturer, by letter November 8, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas, Colorado, Alabama.
QUANTITY 972 cases of 12 bottles each were distributed.
REASON An undetermined number of Hydrogen Peroxide 3% solution
bottles were mislabeled as Isopropyl Rubbing Alcohol.
_______________
PRODUCT Martec brand Hydroxyzine Hydrochloride Tablets, USP, 25 mg,
in bottles of 100, used for neuroses, emotional stress, and
depression. Recall #D-075-5.
CODE Lot LG-1235.
MANUFACTURER Royce Labs, Miami, Florida.
RECALLED BY Manufacturer, by letter November 9, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 824 bottles were distributed.
REASON Side panel of label incorrectly declares 10 mg strength.
Main panel correctly declares 25 mg.
-3- _______________
PRODUCT Ortho-Cyclen 28-Day Regimen (norgestimate/ethinyl
estradiol), Rx oral contraceptive. Recall #D-076-5.
CODE Lot #24K908 EXP 4/97.
MANUFACTURER Ortho-McNeil Pharamceuticals Corporation, Manati, Puerto
Rico.
RECALLED BY Ortho-McNeil Pharmaceutical Corporation, Raritan, New
Jersey, by letter November 28, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 16,027 units were distributed.
REASON Error in declaration of the generic name on the foil-ring.
_______________
PRODUCT Gas Gone Simethicone 80 mg Anti-Gas/Anti-Flatulent Chewable
Tablets, in cartons containing 36 individual blister
packaged tablets, OTC item intended for the fast relief of
gas pain and pressure, labeled as Osco brand and Relief Plus
brand. Recall #D-077-5.
CODE Lot #156-1947 EXP 10/97.
MANUFACTURER Guardian Drug Company, Trenton, New Jersey.
RECALLED BY Manufacturer, by letter January 4, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 398 cases were distributed.
REASON Lack of stability data to support expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT HIV-1 & 2 Elisa Peptide Test for HIV-1 and/or HIV-2
Antibody, 2 well, 48 well and 96 well test kits.
Recall #B-110-5.
CODE ITK2 48F15, 96F15, 96L45.
MANUFACTURER Sero-Immuno Diagnostics, Inc., Tucker, Georgia.
RECALLED BY Manufacturer, by letter February 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 213 to 320 kits were distributed.
REASON Unlicensed product intended as a diagnostic test to screen
for antibodies to Human Immunodeficiency Virus Types 1 and 2
(anti-HIV 1/2) was distributed.
_______________
PRODUCT (a) Red Blood Cells For Further Manufacture;
(b) Platelets; (c) Recovered Plasma. Recall #B-166/168-5.
CODE Unit #5116804.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, (a) by letter June 29, 1994; (b&c) by letters
dated June 28 or 29, 1994. Firm-initiated recall complete.
DISTRIBUTION (a) Illinois; (b&c) Texas, Florida.
-4- QUANTITY 1 unit of each component.
REASON Blood products, in which the sterility of the collection
system was compromised, was distributed.
_______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma.
Recall #B-169/170-5.
CODE Unit numbers: (a) 2214737, 3155822; (b) 3168938, 3172931.
MANUFACTURER Central Texas Regional Blood Center, Austin, Texas.
RECALLED BY Manufacturer, by letters dated August 2 and 4, 1994. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units of each component.
REASON Blood products containing anti-D or anti-E antibodies,
incorrectly labeled as negative for unexpected antibodies,
were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-172-5
CODE Unit #921766.
MANUFACTURER Mary Greeley Medical Center, Ames, Iowa.
RECALLED BY Manufacturer, by telephone July 10, 1992. Firm-initiated
recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus (anti-HIV), was
distributed.
_______________
PRODUCT Source Plasma. Recall #B-173-5.
CODE Unit numbers: XH26864, XH27851, XH28022, XH28676, XH28900,
XH29362, XH29710, XH29810, XH30638, XH30854, XH31223,
XH33061, XH33786, XH34010, XH34345, XH34817, XH38456,
XH39638, XH41949, XH42322, XH45469, XH46450, XH47012,
XH48642, XH50602, XH56534, XH57839, XH60876, XH66533,
XH68359, XH69577, XH70131, XH70650, XH71741.
MANUFACTURER Community Bio-Resources, Inc., Atlanta, Georgia.
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama, by
letter dated May 27, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan and Austria.
QUANTITY 34 units.
REASON Blood products, collected from a donor who previously
provided a history of intravenous (IV) drug use, were
distributed.
-5- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT & Blood products distributed from units collected between
CODE May 3, 1993, and May 27, 1994, and corresponding to the
following inclusive whole blood numbers:
25C48710 - 25C53535, 25E92659 - 25E99943,
25L17964 - 25L19325, 25P23121 - 25P25733,
25P59366 - 25P62730, 25S02800 - 25S03059,
25S51064 - 25S51402, 25V31999 - 25V38402,
25FG23243 - 25GF40157, 25FR37735 - 25FR53669,
25FS00001 - 25FS04057, 25GE15037 - 25GE19971,
25GG09201 - 25GG10472, 25GH28292 - 25GH42599,
25GP22046 - 25GP28644, 25GT10666 - 25GT13883,
25GW30196 - 25GW42249, 25GX12370 - 25GX16648,
25GZ30790 - 25GZ40682, 25LM35697 - 25LM52104.
Recall #B-163-5.
MANUFACTURER American National Red Cross, Syracuse, New York.
RECALLED BY Manufacturer, by letters dated October 10 or 31, 1994.
Firm-initiated recall complete. See also FDA talk paper
T94-52, November 3, 1994.
DISTRIBUTION New York, Connecticut, Georgia, Kansas, Maryland, Minnesota,
Maine, Oklahoma, Pennsylvania, Vermont.
QUANTITY 79,351 units.
REASON Blood products, which may have tested weakly reactive in the
Macro-Vue Rapid Plasma Reagin (RPR) Test, and interpreted as
non-reactive, contrary to the manufacturer's directions,
were distributed.
_______________
PRODUCT (a) Whole Blood CPD; (b) Red Blood Cells.
Recall #B-164/165-5.
CODE Unit numbers: (a) 5004205, 5004217, 5004230; (b) 0134321,
2236370, 0326893, 4590873, 5003417, 7759081.
MANUFACTURER North Jersey Blood Center, East Orange, New Jersey.
RECALLED BY Manufacturer, by telephone January 7 and 12, 1994. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY (a) 3 units; (b) 6 units.
REASON Blood products which were labeled with an incorrect
expiration date were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-171-5.
CODE Unit numbers: 6139659, 6139678.
MANUFACTURER Blood Center of Southeast Texas, Inc., Beaumont, Texas.
RECALLED BY Manufacturer, by telephone May 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units.
REASON Blood products which were labeled with an incorrect
expiration date were distributed.
-6- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Vortran Medical Technology MiniHeartTM Nebulizer (MiniNEB),
low volume medication nebulizer. Recall #Z-424-5.
CODE Lot numbers: 9201-5000, 9302-5000, 9304-5000, 93001, 94004
(Vortran); 080192, 021593 (BCB).
MANUFACTURER Vortran Medical Technology, Inc., Sacramento, California.
RECALLED BY Manufacturer, by letters dated June 27 and 30, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Arkansas, California, Connecticut, Georgia, Indiana,
Louisiana, Massachusetts, Michigan, Minnesota, Missouri,
Pennsylvania, Rhode Island, Tennessee, Texas, Washington
State, Italy, Taiwan.
QUANTITY 24,840 were distributed.
REASON The nebulizer flow rates are lower than the rates reported
on the labeling.
_______________
PRODUCT Proof Biological Indicators, for use in monitoring ethylene
oxide sterilization procedures:
(a) Proof Ethylene Oxide Biological Indicator;
(b) Proof Steam Biological Indicator. Recall #Z-451/452-5.
CODE Lot numbers: (a) PG074A; (b) PS094A.
MANUFACTURER American Sterilizer Company, Erie, Pennsylvania.
RECALLED BY Manufacturer, by letter January 13, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Minnesota.
QUANTITY 1 case containing 100 indicators was distributed.
REASON The firm was distributing product without 510(k) clearance.
_______________
PRODUCT Force GSU Argon Enhanced Electrosurgical Systems:
(a) Catalog Number Force GSU-20;
(b) Catalog Number Force GSU-22. Recall #Z-459/460-5.
CODE All serial numbers.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter April 21, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 840 units.
REASON Certain component failures in the software control system
could cause the argon gas flow rate to increase to
potentially hazardous levels.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Triad Visible Light Cure (VLC) Denture Base Material Sheets,
used to make molds to form dentures:
(a) Item 89781 - Regular Pint Unfibered (RPU);
(b) Item 9574201 - Light Pink Fibered (LPF)
(c) Item 9574202 - Regular Pink Fibered (RPF).
Recall #Z-166/168-5.
-7- CODE Lot numbers: (a) 931228B; (b) 931230B; (c) 931231B.
MANUFACTURER Dentsply International/York Division, York, Pennsylvania.
RECALLED BY Manufacturer, by letter February 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 7 cases (150 units per case); (b) 411 cases (6 units per
case); (c) 26 cases (6 units per case) were distributed.
REASON Denture base material was not curing properly.
_______________
PRODUCT Microtainer brand Tube with EDTA(K2), intended for the
collection, transport and processing of skin puncture or
capillary blood. Recall #Z-453-5.
CODE Catalog #365974; lot #3M556.
MANUFACTURER Becton Dickinson, Vacutainer Systems Micropette, Inc., San
Lorenzo, Puerto Rico.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New
Jersey, by letter dated August 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California, Washington State.
QUANTITY 24,200 units were distributed; firm estimated that 13,400
units remained on market at time of recall initiation.
REASON Labeling error. The case cartons were labeled with
"Experimental Use Only" label which should have been removed
before shipping.
_______________
PRODUCT Vacutainer brand Plus Evacuated Blood Collection with
Lithium Heparin, used for the collection and transport of
venous blood. Recall #Z-444-5.
CODE Catalog #367889, lot #3Q075.
MANUFACTURER Becton Dickinson Vacutainer Systems, Plymouth, England.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New
Jersey (responsible firm), by letter July 15, 1994. Firm-
initiated recall complete.
DISTRIBUTION California, Georgia, Illinois, Maryland, Minnesota, New
Jersey, Oklahoma, and Texas.
QUANTITY 33,600 units were distributed; firm estimates none remains
on the market.
REASON Shelf cartons were labeled with the incorrect expiration
date of September 15, 1994 rather than the correct date of
February 15, 1994. The use of the collection tube after the
correct expiration could result in a loss of vacuum which
would result in less than expected volume of blood
collection and a higher anticoagulant blood ratio.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- Class II
===========
_______________
PRODUCT Bulk Geno-Phase sold under the brand name 58 LY Supplement,
a swine feed medicated with tylosin. Recall #V-019-5.
CODE Lot numbers: 20062 and 20063 manufactured 3/17/94.
-8- MANUFACTURER NuMac, Inc., Walker, Iowa.
RECALLED BY Manufacturer, by telephone March 21, 1994, followed by
letter March 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 2 1-ton batches were distributed.
REASON Possible contamination with sulfamethazine due to inadequate
clean out procedures.
SEIZURES:
=================================================================
_______________
PRODUCT Nystatin Oral Suspension, USP, and Carbamazepine
Suspension, USP (95-741-386).
CHARGES Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
LOCATION Xactdose, Inc., South Beloit, Illinois.
FILED February 9, 1995; U.S. District Court for the Northern
District of Illinois, Western Division; Civ. #95C 50041;
FDC #67058.
SEIZED February 13, 1995 - goods valued at approximately $294,735.
_______________
PRODUCT Canned Mushrooms (95-786-249).
CHARGES Adulterated - The article contains an added poisonous and
deleterious substance, staphylococcal enterotoxin, which may
render it injurious to health; and it has been prepared and
packed under conditions whereby it may have been rendered
injurious to health. Misbranded - The article's labeling is
false and misleading because it represents and suggests that
the article was packed in Hong Kong, which is contrary to
fact.
LOCATION Asia Foods, Philadelphia, Pennsylvania.
FILED January 27, 1995; U.S. District Court for the Eastern
District of Pennsylvania; Civ. #95-483; FDC #67056.
SEIZED February 3, 1995 - goods valued at approximately $2,128.
-9-
END OF ENFORCEMENT REPORT FOR MARCH 1, 1995. BLANK PAGES MAY
FOLLOW.
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