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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
September 2, 1998

PRODUC T
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.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.