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
09/17/1991
Enforcement Report for the week of September 18, 1991
September 18, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Sunny Delight Florida Citrus Punch, in 64 ounce
plastic containers. Recall #F-529-1.
Code: NOV 07L, NOV 08L.
Manufacturer: Sundor Brands, Inc., Chicopee, Massachusetts.
-1-
Recalled by: Proctor & Gamble, Cincinnati, Ohio, by telephone
July 12, 1991. Firm-initiated recall ongoing.
Distribution: New York, New Jersey, Vermont.
Quantity: 2,932 cases were distributed.
Reason: Bottle caps are contaminated with sodium hydroxide.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Mrs. Paul's Deviled Crabs and Deviled Crab Miniatures.
Recall #F-526/527-1.
Code: USED BY DATES: 17 OCT 92, 18 OCT 92, 17 NOV 92,
08 NOV 92, 03 DEC 92, 04 DEC 92.
Manufacturer: Mrs. Paul's Kitchens, Inc., Subsidiary of Campbell Soup
Company, Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by letter July 22, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 40,560 cases were distributed.
Reason: Product contains undeclared sulfites.
----
Product: Nature Made Daily Combo Vitamins, in 100 tablet
bottles. Recall #F-528-1.
Code: Lot #00119906 EXP 8/15/92.
Manufacturer: Pharmavite Corporation, San Fernando, California.
Recalled by: Pharmavite Corporation, Mission Hills, California, by
letters of May 16 and 21, 1990. Firm-initiated recall
complete.
Distribution: Nationwide.
Quantity: 2,819 bottles were distributed; firm estimates none
remains on the market.
Reason: Product was incorrectly labeled as ferrous sulfate.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
-2-
Class II -
Product: Approximately 1,000 Rx and OTC repackaged drug products,
all potencies, all lots and all sizes. Recall #D-628-1.
Code: All lots.
Manufacturer: Multiple firms.
Recalled by: Tennessee Drug Repack, Inc., Parsons, Tennessee (repacker/
responsible firm), by telephone August 21, 1991, followed
by letter August 23, 1991. Firm-initiated recall ongoing.
Distribution: Tennessee.
Quantity: Unknown. However, the recalling firm repacked approximately
4.5 million unit-dose packets during the six month period
prior to the initiation of this recall action.
Reason: Unit-dose repacking of partial tablets, current good
manufacturing practice deficiencies and use of non-permitted
expiration dates.
----
Product: Qualitest brand Hemorrhoidal Suppositories with
Hydrocortisone Acetate, 25 mg, an Rx product.
Recall #D-630-1.
Code: Lot #104086 EXP 4/93.
Manufacturer: Able Laboratories, Inc., S. Plainfield, New Jersey.
Recalled by: Manufacturer, by letter June 19, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 8,616 boxes (12 units per box) were distributed.
Reason: The product containing 25 mg Hydrocortisone Acetate was
packed in cartons labeled as 10 mg Hydrocortisone
Acetate.
----
Product: (a) Sulfatrim Pediatric Suspension;
(b) Sulfatrim Suspension, both in 16 ounce bottles, Rx
drug products under the Barre-National, Moore, Geneva,
Goldline and Schein labels. Recall #D-639/640-1.
Code: Lot numbers: (a) 92618 EXP 10/92; (b) 92617 EXP 10/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: (a) 23,292 bottles; (b) 46,894 bottles were
distributed; firm estimates none remains on the market.
Reason: Products fail stability specifications.
----
-3-
Product: Lindane Lotion 1%, in 2 and 16 ounce bottles, an Rx
drug indicated for the treatment of patients infested
with Sarcoptes scabiei (scabies), under the Barre-National,
Goldline, Rugby and Moore labels. Recall #D-642-1.
Code: Lot #03672 (2 oz) EXP 9/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 86,688 bottles were distributed; firm estimates 15,145
bottles remain on the market.
Reason: Presence of mold in some units.
----
Product: Cryoprecipitated AHF. Recall #B-403-1.
Code: Unit #Y01631.
Manufacturer: Champaign County Blood Bank, Urbana, Illinois.
Recalled by: Manufacturer, by telephone June 26, 1991, followed by
letter June 27, 1991. Firm-initiated recall complete.
Distribution: Illinois.
Quantity: 1 unit.
Reason: Blood product containing anti-D antibodies, but labeled
as negative for unexpected antibodies, was distributed.
----
Class III -
Product: Fluorouracil Injection USP, 50 mg/ml, in 100 ml vials,
10 vials per shipping carton, pharmacy bulk package, not
for direct infusion, an Rx intravenous drug for the
palliative management of carcinoma of the colon, rectum,
breast, stomach and pancreas. Recall #D-629-1.
Code: Catalog #01290, lot #901010 EXP 4/92.
Manufacturer: Smith & Nephew SoloPak, Elk Grove Village, Illinois.
Recalled by: Manufacturer, by letter August 29, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 10,820 units were distributed; firm estimates 400 units
remain on the market.
Reason: The product may contain dark particulate matter.
----
Product: Barophen Elixir, an Rx drug for use as adjunctive
therapy in the treatment of irritable bowel syndrome and
acute enterocolitis, in 4 ounce, 16 ounce, and 1
gallon bottles. Recall #D-631-1.
Code: Lot numbers: 92883 EXP 2/93, 03578 EXP 8/93, 03630
EXP 9/93, 03788 EXP 12/93, 13203 EXP 5/94.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
-4-
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 111,050 units were distributed; firm estimates 12,801
units remain on the market.
Reason: Use of unapproved test for analysis.
----
Product: Glycerin, in 4 and 16 ounce bottles, an OTC product
under the Barre-National and Schein label.
Recall #D-632-1.
Code: All lots within expiration dates.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 320,177 units were distributed; firm estimates 25,743
units remain on the market.
Reason: Lack of assurance that product meets specifications
through expiration date.
----
Product: (a) Dihistine DH Elixir; (b) Dihistine Expectorant;
(c) Guiatuss AC; (d) Guiatuss DAC, in 4 ounce, 16 ounce
and in 1 gallon bottles, Rx cough/cold products.
Recall #D-633/636-1.
Code: All lots within expiration dates.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,319,280 units were distributed.
Reason: Products fail to meet stability specification for
codeine phosphate ingredient.
----
Product: SoloPak Heparin Lock Flush, Preservative Free, 10 units
per ml Injection, USP, a Rx drug used to maintain
patency of an indwelling venipuncture device designed
for intermittent injection or infusion therapy or
blood sampling (not for anticoagulant therapy), in the
following packaging types and sizes:
(a) 1 ml single dose vial, Catalog #01801, 25 vials
per tray. Also packaged under the Goldline label,
Catalog #CP326;
(b) 2 ml single dose vial, Catalog #01802, 25 vials
per tray. Also packaged under Smith & Nephew label,
Catalog #501802 and Goldline label, Catalog #CP327;
-5-
(c) 5 ml single dose vial, Catalog #01805, 25 vials
per tray;
(d) 1 ml Hy-Pod Prefilled Syringe, Catalog #10671.
Also packed in the following kits: Lok-Pak-N 1 ml
Heparin Lock Flush Procedure Pack; SoloPak Laboratories,
Catalog #11771; and Baxter Heparin Lock Flush Solution,
USP with InterLink Cannula, Catalog #2N3270 (CP302).
Sold separately in bulk boxes of 100 under catalog #CP312;
(e) 3 ml Hy-Pod prefilled syringe, Catalog #10673.
Also packed in the following kit: Lok-Pak-N 3 ml Heparin
Lock Flush Procedure Pack, Catalog #11773;
Baxter Heparin Lock Flush Solution, USP with InterLink
Cannula, Catalog #2N3272 (CP304). Sold separately in bulk
boxes of 100 under catalog #CP314;
(f) 5 ml Hy-Pod Prefilled syringe, Catalog #10675.
Also packed in the following kit: Lok-Pak-N 5 ml
Heparin Lock Flush Procedure Pack, Catalog #11775.
Recall #D-637-1.
Code: All lots of catalog numbers 10671, 11771, 10673, 11773,
10675, 11775, 01801, 01802 and 01805.
Catalog #CP326, Lot #910541A;
Catalog #CP327, Lot #910733A1;
Catalog #501802, Lot #910346A, 910733A, 900312A;
Catalog #CP302, Lot #90C001A 90L002A, 91D017A1, 91E016A;
Catalog #CP312, Lot #90M001A, 91C006A, 91D017A, 91F014A;
Catalog #CP304, Lot #90D004A, 90L003A, 91C020A, 91D013A;
Catalog #CP314, Lot #91C020A1.
Manufacturer: Smith & Nephew Solopak, Elk Grove Village, Illinois.
Recalled by: Manufacturer, by letter September 1, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 220,820 cases (24 vials per case) and 22,542 cases
(600 syringes per case) were distributed; firm
estimates that 2,000 cases of vials and 1,000 cases
of syringes remain on the market.
Reason: Potency cannot be assured through expiration date.
----
Product: Maybelline Moisture Whip Liquid Make-up with sunscreen,
product #150 FM-02, beige for medium skin, in 1 fluid
ounce bottles. Recall #D-638-1.
Code: Lot 1G120.
Manufacturer: Maybelline Products Company, Inc., North Little
Rock, Arkansas.
Recalled by: Manufacturer, by letter August 6, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 11,892 bottles were distributed.
Reason: Presence of metal fragments.
----
-6-
Product: Lidocaine HCl 2% Viscous, oral topical solution, in
100 ml bottles, an Rx drug indicated for the production
of topical anesthesia of irritated or inflamed mucous
membranes of the mouth and pharynx. It is also used for
reducing gagging during the taking of x-ray pictures and
dental impressions, under the Barre, United Research
Laboratories (URL) Major, Schein, Goldline, Bioline and
Moore labels. Recall #D-641-1.
Code: Lot #03564 EXP 10/92.
Manufacturer: Barre-National, Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 38,997 bottles were distributed.
Reason: Product fails stability test for viscosity specifications.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Platelets, Pheresis. Recall #B-398/401-1.
Code: Unit numbers: (a) 53C32714, 53F57495, 53FH08419,
53J33602, 53J33603, 53J33604, 53J33606, 53V28244;
(b) 53C32708, 53C32709, 53C32710, 53C32715, 53FC12373,
53FC12374, 53FH08425, 53FH08426, 53FH08427, 53FH08428,
53FH08429, 53G50206, 53G50207, 53J33604, 53J33605,
53V28238, 53V28242;
(c) 53C32708, 53C32709, 53C32710, 53C32711, 53C32712,
53C32715, 53C32716, 53F57503, 53F57507, 53F57509, 53F57510,
53J33596, 53J33599, 53J33604, 53J33605, 53V28236, 53V28237,
53V28238, 53V28239, 53V28240, 53V28241, 53V28243;
(d) 53LT22750, 53LT22751, 53LT22752, 53LT22753, 53LT22754,
53LT22756, 53LT22758, 53P34929, 53P34930, 53P34931,
53P34933, 53P34935, 53P34936, 53P34937, 53P34938.
Manufacturer: American Red Cross, Baltimore, Maryland.
Recalled by: Manufacturer, by letter May 1, 1991. Firm-initiated
recall complete.
Distribution: Pennsylvania, Maryland, Washington, D.C.
Quantity: (a) 8 units; (b) 17 units; (c) 22 units; (d) 15 units.
Reason: Blood products, incorrectly tested for the antibody to
the hepatitis C virus (anti-HCV), were distributed.
----
Product: Red Blood Cells, Washed. Recall #B-402-1.
Code: Unit #32F41868.
Manufacturer: American Red Cross Blood Services, Madison, Wisconsin.
Recalled by: Manufacturer, by letter May 31, 1991. Firm-initiated
recall complete.
Distribution: Wisconsin.
Quantity: 1 unit.
-7-
Reason: Red Blood Cells, Washed, not labeled with the time of
expiration, were distributed.
----
CORRECTION: The recall number for Red Blood Cells, manufactured by
American Red Cross, Greater Upstate New York Region,
Syracuse, New York, which appeared in the September 11, 1991,
Enforcement Report as Recall #B-387-1 should read
Recall #B-405-1.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: All sizes of silicone gel-filled mammary breast prostheses:
(a) Enhanced High Profile (EHP);
(b) DRIE Reverse Double Lumen (RDD);
(c) DRIE II Round Low Profile (DRI);
(d) Single Lumen Saline Adjustable (SLP);
(e) DRIE Round High Profile (RHD);
(f) Mammary Sizer (SZR);
(g) Saline-Gel Round (SGR);
(h) Oval High Profile (OHP);
(i) Oval Low Profile (OLP);
(j) DRIE Round Low Profile (RLD);
(k) Round High Profile (RHP);
(l) Round Low Profile (RLP). Recall #Z-1005/1016-1.
Code: All lots.
Manufacturer: CUI Corporation, Carpinteria, California.
Recalled by: Manufacturer, by letters of July 11, 1991,
August 1 and 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 103,000 units were distributed.
Reason: The silicone gel-filled breast prostheses (SGFBP) were on
the market after July 9, 1991 without a premarket approval
application (PMA), as required by the final rule of April
10, 1991, pursuant to Section 515(b) of the FD&C Act.
----
Class III -
Product: RNA-Medical Qualidata Blood Gas Controls, used to
measure parameters of blood gas instruments and for
in-vitro diagnostic use:
(a) Catalog #QC-123 (Multi-Level),
Level 1, Level 2, and Level 3;
(b) Catalog #QC-123-3 (Level 3) Only Level 3
effected in recall. Recall #Z-1031/1032-1.
-8-
Code: Lot numbers: (a) 0134 EXP 1/93 (Level 1)
0236 EXP 2/93 (Level 2), 0336 EXP 2/93 (Level 3);
(b) 49303 EXP 7/31/93,
Manufacturer: Bionostics, Inc., Acton, Massachusetts.
Recalled by: Manufacturer, June 17, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 4,000 units were distributed.
Reason: Product may have been packed with the wrong level-3 material.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Iodine Tincture Strong, 7% Iodine in 16 ounce and
1 gallon containers, an OTC topical liquid antiseptic
disinfectant for application to superficial cuts,
abrasions, insect bites, and minor bruises, under
the following labels: Chesterfield Laboratories,
Butler Co., Phoenix Pharmaceutical, and VEDCO, Inc.
Recall #V-079-1.
Code: Lot numbers: 900384, 900385, 900460, 91008, 910070.
Manufacturer: Chesterfield Laboratories, Inc., Riverside, Missouri.
Recalled by: Manufacturer, by letter May 1, 1991 and May 3, 1991.
Firm-initiated recall ongoing.
Distribution: Wisconsin, California, Ohio, Arizona, Pennsylvania,
Nebraska, Missouri, New Mexico, Kansas, Florida.
Quantity: 756 1-gallon containers and 1,860 16-ounce containers
were distributed.
Reason: The product is subpotent.
----
Product: Veterinary parenteral products:
(a) Oxy-Mycin 100 Oxytetracycline HCl Injection, in 500 ml
bottles, an OTC sterile liquid for intravenous
administration, for the treatment of diseases in beef
cattle, beef calves, nonlactating dairy cattle, and dairy
calves;
(b) Sodium Iodide 20%, in 250 ml bottles, an OTC sterile
liquid for intravenous administration, as an aid in the
treatment of actinomycosis (lumpy jaw) and actinobacillosis
(wooden tongue, necrotic stomatitis) in cattle, under the
Techamerica, The Butler Co., and Lextron labels;
-9-
(c) Techamerica Electro Solution with Dextrose, in
950 ml bottles, a sterile liquid for intravenous
administration, as a fluid and electrolyte replenisher
in the treatment of dehydration and electrolyte depletion
accompanying diarrhea or severe hemorrhage in cattle;
(d) Techamerica Sterile Physiological Saline Solution,
in 250 ml bottles, an OTC sterile liquid for injection
infusion, or local application, for diluting veterinary
penicillin or other drugs and biologic products used in
livestock;
(e) Techamerica Sodium Bicarbonate, in 500 ml bottles, an
Rx sterile liquid for intravenous injection in cattle,
horses, sheep, and swine, as an aid in the treatment of
metabolic acidosis;
(f) Techamerica Sterile Water for Injection, in 250 ml
bottles, an OTC product for diluent use;
(g) Methylprednisolone Acetate Injection Sterile Aqueous
Suspension, in 5 ml bottles, an Rx product for intramuscular
or intrasynovial injection in dogs and horses and intra-
muscular injection in cats, for use as a glucocorticoid
and anti-inflammatory agent;
(h) Cyanocobalamin Injection Vitamin B12 Injection,
1000 mcg/ml, in 500 ml bottles, an OTC product for
subcutaneous or intramuscular administration, for use as
a nutritional supplement for ruminating cattle and calves
that are off-feed due to environmental conditions, shipping
stress, or disease, especially accompanied by diarrhea,
under the Rx Veterinary Products, Durvet, and Lextron labels;
(i) Fortified Vitamin B Complex Injectable Sterile Solution,
in 500 ml bottles, an OTC product for intramuscular or
subcutaneous administration, for use as a sterile aqueous
solution of B complex vitamins to provide a supplemental
nutritional supply of these vitamins to cattle, horses,
sheep, swine, and small animals (dogs and cats), under the
Agri Laboratories, Durvet, and Rx Veterinary Products labels.
Recall #V-080/088-1.
Code: Lot numbers: (a) 040PM05 APR. 93; (b) 040EN01 APR 93
and 9136A MAY 92; (c) 010EL01 EXP 9/93; (d) 040EY01 APR 93,
8208C JUL 91, and 8120A APR 91; (e) 9342B DEC 92 and 8214D
AUG 91; (f) 040EW01 APR 93 and 8123A MAY 91;
(g) 9289 OCT 91 and 9100A APR 91 (h) 9114A APR 92;
(i) 9213A AUG 91.
Manufacturer: Fermenta Animal Health Company, Elwood, Kansas.
Recalled by: Manufacturer, by letter March 25, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 8,520 bottles; (b) 10,474 bottles; (c) 2,400 bottles;
(d) 13,750 bottles of lot 8120A, 14,714 bottles of lot 8208C,
6,336 bottles of lot 040EY01; (e) 3,677 bottles of lot 8214D,
3,336 bottles of lot 9342B; (f) 14,496 bottles of lot 8123A,
2,461 bottles of lot 040EW01; (g) 3,058 bottles of
lot 9100A, 3,326 bottles of lot 9289A;
-10-
(h) 7,326 bottles; (i) 7,219 bottles were distributed;
firm estimates none remains on the market.
Reason: Firm failed to comply with current good manufacturing
practice regulations in manufacture of parenteral veterinary
drugs, including inadequate validation of the aseptic
filling operation and inadequate sterility testing.
----
Class III -
Product: VEDCO brand Disposable Enema, 12 ml syringe, an OTC product
for use as an aid in the relief of all forms of constipation
for preoperative preparations and for restoration of
bowel habits in postoperative patients, for dogs and
cats. Recall #V-077-1.
Code: Lot numbers: B163 and B166.
Manufacturer: Sparhawk Laboratories, Inc., Kansas City, Kansas.
Recalled by: Innotech, Inc., Kansas City, Missouri, by letter
January 25, 1991. Firm-initiated recall ongoing.
Distribution: Missouri.
Quantity: 2,880 syringes were distributed.
Reason: The product is an unapproved new animal drug.
----
Product: Kent pasture Aid Mineral 1440B (Lasalocid), in 50 pound
bags, a free choice supplement containing 1,440 G/ton
Lasalocid, OTC, for increased rate of weight gain in
pasture cattle. Recall #V-090-1.
Code: Lot #194Z.
Manufacturer: Kent Feeds, Inc., Marshall, Missouri.
Recalled by: Manufacturer, by telephone June 18, 1991. Firm-initiated
recall complete.
Distribution: Missouri.
Quantity: 120 bags were distributed; firm estimates none
remains on the market.
Reason: The product is subpotent.
####
-11-