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.
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
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.
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
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.
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.