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.

September 2, 1998 98-35

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
"Sea Specialties PREMIUM QUALITY MAMA'S SMOKED SALMON NOVA SNACKS NET WT 8 OZ." Product is labeled to be refrigerated and is packed into a plastic "vacuum" pack. Recall #F-592-8.

CODE
Only "Sell By" date of "12/28/98" is involved.

MANUFACTURER
Sea Specialties, dba as Florida Smoked Fish Co., Miami, FL

RECALLED BY
Manufacturer, by phone on August 7, 1998, faxed Press Release on late August 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Florida (Southeast Coastal Florida).

QUANTITY
Approximately 100 cases were distributed of the recalled lot.

REASON
Productsis contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT
Cajun Smoked Salmon Spread in 7 ounce cups, 12 ounce cups and 5 pound buckets distributed by Future Food, Randell's and Bi-Lo Stores. Recall #F-590-8.

CODE
Lots dated 8/19/98 and before.

MANUFACTURER
Bartush-Schnitzius Foods Co.(BSFC), Lewisville, Texas Heritage Family Specialty Foods (HFSF), Grand Prairie, Texas

RECALLED BY
Future Food, Inc., Dallas, Texas, by letter on July 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
2670 cases 12/7 ounce cups, 520 12/12 ounce cups, and 4072 2/5 pound buckets.

REASON
Products contains undeclared wheat FD&C Yellow #5 and FD&C Red #40.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______ PRODUCT
Amway brand "FORMUCARE" Triple Antibiotic Ointment (Bacitracin-Neomycin Sulfate-Polymyxin B Sulfate), net wt. 28.35 g (1 oz.). An OTC topical antibiotic used for first aid. Manufactured for Amway Corporation, Ada, MI. Recall #D-230-8.

CODE
Lot M255, expiration date 1/2000 Lot M211, expiration date 12/1999

Amway product codes: Triple antibiotic ointment A-5600; Antifungal Cream A-5569.

MANUFACTURER
Thames Pharmacal Co., Inc., Ronkonkoma, New York.

RECALLED BY
Manufacturer, by verbal direction to distributer on May 18, 1998 and by letter August 3, 1998. Firm-initiated recall on-going.

DISTRIBUTION
Amway Coporation, East Ada, Michigan.

QUANTITY
1,308.5 cases were distributed.

REASON
Mispackaging - some tubes of Amway brand "FORMUCARE" Antifungal Cream were packaged into cartons labeled "Formucare" Triple Antibiotic Ointment and distributed.

________ PRODUCT
Pyrinyl Shampoo in 2, 4 and 8 oz containers used in the treatment of head, pubic and body lice. Recall #D-231-8.

CODE

Lot No.   NDC No.        Size Exp Date  Label

RK7600    11822-1583-4        4 oz 11/99          Rite Aid
RK7600    211158394           4 oz 11/99          Rite Aid

RL7708    0472-1583-94        4 oz 11/99          Alpharma
RL7708    0904-2528-20        4 oz 11/99          Major

RK7711    41163-1583-4        4 oz 10/99          Albertson's
RK7711    11822-1583-4        4 oz 10/99          Rite Aid
RK7711    0472-1583-94        4 oz 10/99          Alpharma

RN7792    49348-443-34        4 oz 12/99          Valurite
RN7792    41163-1583-4        4 oz 12/99          Rite Aid
RN7792    0904-2528-20        4 oz 12/99          Major
RN7792    11822-1585-4        4 oz 12/99          Rite Aid
RN7792    41131-1583-4        4 oz 12/99          Home Best

RS7972    11822-1583-8        8 oz 01/00          Rite Aid
RS7972    0472-1583-92        2 oz 01/00          Alpharma  
RS7972    6021986             2 oz 01/00          Rugby

RP7914    0472-1583-94        4 oz 03/00          Alpharma
RP7914    11822-1583-4        4 oz 03/00          Rite Aid

MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland. Alpharma label and private labels to include: Rite Aid, Major, Albertson's, Valurite, Home Best and Rugby.

RECALLED BY
Manufacturer, by letter certified mail on/about 8/14/98. Firm initiated recall on-going.

DISTRIBUTION
Nationwide.

QUANTITY
RK7600 - 30,409 units produced/30,384 units distributed. RL7708 - 28,270 units produced/28,224 units distributed. RK7711 - 30,484 units produced/30,348 units distributed. RN7792 - 30,713 units produced/25,656 units distributed RS7972 - 58,204 units produced/45,348 units distributed RP7914 - 75,648 units produced/5,184 units distributed. A total of 165,144 units were shipped.

REASON
Pyrethrins was calculated incorrectly for the raw material.

_______ PRODUCT
Doxorubicin Hydrochloride for injection. Recall #D-232-8.

CODE
Lot No. 22102

MANUFACTURER
Ben Venue Labortories, Beford, Ohio.

RECALLED BY
Manufacturer, by letter on August 13, 1998.

DISTRIBUTION
Nationwide, Peurto Rico

QUANTITY
13,920 vials

REASON
Product exceeds shelf life moisture.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______ PRODUCT
a)Red Blood Cells, b)Platelets, c)Fresh Frozen Plasma, d)Cryoprecipitated AHF, e) Plasma, f)Recovered Plasma, g) Red Blood Cells, for further manufacturing. Recall #B-1506/B-1513-8.

CODE
Unit# 42X95806

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letters on March 28, 1997 and April 13, 1998. Firm-initiated recall on-going.

DISTRIBUTION
Ohio, California, New York, Florida, Massachusetts and Switzerland.

QUANTITY
a)130 units, b)67 units c)3 units d)2 units e) 20 units f)108 units g)7 units.

REASON
Blood products,which tested negative for antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1 and were improperly reentered, were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ PRODUCT
Power Lifts marketed under the trade name AReliant Power Lift@. Recall # Z-779/781-8.

CODE
80 FSA Models: RPA450, RPL450, and RPA600. All serial numbers above referenced Model Numbers of the Reliant Power Lifts manufactured between November, 1996 and January 1998, are subject to recall.

MANUFACTURER
Invacare Corporation, Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone, fax, Fed X, on July 28, 1998. Firm-initiated recall on-going.

DISTRIBUTION
Nationwide.

QUANTITY
722 patient power lifts are currently in distribution.

REASON
The linear actuator shaft may break while in use, resulting in a patient falling from the lift.

_______ PRODUCT
Midmark Surgical Lounge Stretch, Model 547. Recall #Z-783-8.

CODE
TFW001000 through TFW001059.

MANUFACTURER
Midmark Corporation, Versailles, Ohio.

RECALLED BY
Manuacturer, by telephone on July 28-30, 1998 and by letter dated July 30, 1998.

DISTRIBUTION
Florida, Hawaii, Texas, New York, Conneticut.

QUANTITY
22 Strechers.

REASON
There is a potential for the weld between the side rail and the spur gear to fail causing the side rail to drop without warning.

_______ PRODUCT
Promotional Material on Coronary Stent System. Recall # Z-788-8.

CODE
Not applicable.

MANUFACTURER
Guidant ACS/DVI, Temecula, CA.

RECALLED BY
Manufacturer, by letter on June 12 and June 30, 1998. Firm-initiated recall on-going.

DISTRIBUTION
Nationwide.

QUANTITY
211 physicians.

REASON
Unauthorized newsletters were sent containing inappropriate use of the device.

_______ PRODUCT
Titanium plasma sprayed (TPS) cyclindrical Endosseous Dental Implants and Hydroxylapatite (HA) coated cylindrical Endosseous Dental Implants. Recall #Z-804/819-8.

CODE
CATALOG NUMBER LOT NUMBER


HH315                         48240
HP410                         47452
HP413                         48241
HP415                         43413
HP415                         43975
TH310                         39751
TH310                         44851
TH310                         48292
TH313                         40047
TH313                         40570
TH313                         43184
TH313                         47451
TH315                         38149
TH315                         43183
TP485                         39750
TP485                         43182
TP410                         38147
  "                           39752
  "                           41240
  "                           44002
  "                           44850
  "                           46213
  "                           46928
  "                           47950
TP413                         40568
  "                           42111
  "                           47301
  "                           43763
  "                           45023
TP415                         38148
  "                           38150
  "                           39208
  "                           40567
  "                           43185
  "                           46841
TP418                         44853
TP418                         47949
TP585                         48367
TP510                         37978
  "                           39491
  "                           39745
  "                           47951
  "                           40571
  "                           43414          
  "                           43976
TP513                         37334
  "                           37979
  "                           39492
  "                           39746
  "                           40569
  "                           44852
  "                           47952
TP610                         34192
  "                           38151
  "                           40566
  "                           47953
  "                           47954

MANUFACTURER
Implant Innovations, Palm Beach Gardens, FL.

RECALLED BY
Maufacturer, by telephone on June 9, 1998. Firm-initiatied recall on-going.

DISTRIBUTION
Nationwide and International

QUANTITY
3,914 implants were shipped.

REASON
The Sterile Barrier packaging may have a hole in the outer pouch.

RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II

_________ PRODUCT
PHASE-II-Instantized Milk Replacer Medicated 25 lb bags/50 grams/ton chlortetracycline - for increased rate of weight gain and improved feed efficiency. Recall #V-028-8

CODE
March 12, 1998; May 5, 1998; April 7, 1998; May 15, 1998; April 15, 1998; June 5, 1998; April 22, 1998; June 17, 1998.

MANUFACTURER
Milk Products, Inc. Chilton, Wisconsin.

RECALLED BY
Manna Pro Corporation, St. Louis, Missouri, by fax on June 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado, Kansas, Ohio, Georgia, Pennsylvania, Flordia and Calfornia.

QUANTITY
3,296 25lb bags.

REASON
Product was incorrectly labled to contain 50g/ton chlortetracycline. Product actually contained 20 g/ton oxytetracycline.

_______ PRODUCT
Country Lane 24-10 Instantized Calf Milk Replacer Medicatd, 25lb bags/100 grams/ton chloretracycline - to aid in the prevention of bacterial diarrhea. Recall #V-029-98.

CODE
May 29, 1998; June 5, 1998; June 17, 1998; June 29, 1998.

MANUFACTURER
Milk Products, Inc. Chilton, Wisconsin.

RECALLED BY
Manna Pro Corporation, St. Louis, Missouri, by telephone on June 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kansas.

QUANTITY
1,770 25 lb bags.

REASON
Product was incorrectly labled to contian 100 g/ton chlortetracycline. Product actually contained 20 g/ton oxtetracycline.

_______ PRODUCT
Endosorb Suspension, Activated Attapulgite in Aqueous Suspension, for use to help alleviate the symptoms of simple diarrheas in animals. Recall #V-030-8.

CODE
Lot #980308

MANUFACTURER
Performance Products, Inc., St. Louis, MO.

RECALLED BY
Manufacturer, by phone on May 12, 1998, and by fax and by letter May 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
The firm has distributed 3,394/4-fl. oz., 144/16-fl. oz., and 120/1-gallon containers between 3/20-26/98.

REASON
Product was contaminated with gram negative bacilli in the suspension and varying degrees of microbes in the active ingredient attapulgite.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 2, 1998.

####