Qualitest Pharmaceuticals recalls PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOON…

Recall date

February 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0411-2015

FDA classification

Class II

Brand / firm

Qualitest Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.