drugs Class II Updated 2015-03-18

Qualitest Pharmaceuticals recalls PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and D

Recalled Product

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.

Hazard / Issue

Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 0000001099; Exp. 03/16
View official government recall

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