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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 19, 1998

PRODUCT
Allergy Medication Capsules (Diphenhydramine) 25 mg, OTC, packaged for American Sales, which distributes the product under the Stop & Shop and Finast labels, in 100 capsule bottles. Recall #D-221-8.

CODE
Lot Numbers: 7049878, 7049633, 7072823, 8064755, 7117566, 7118008, 7095452.

MANUFACTURER
Granutec, Inc., Largo, Florida.

RECALLED BY
Granutec, Inc., Wilson, North Carolina, by telephone on August 4, 1998, followed by letter on August 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
28,386 units were distributed.

REASON
Mislabeling - Product bears the tamper resistant instructions for blister packaged product not bottled product.

 

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.