FDA-Drug2015-03-18Class II
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.
Qualitest Pharmaceuticals
Hazard
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Sold states
Nationwide
Affected count
972 bottles
Manufactured in
120 Vintage Dr NE, N/A, Huntsville, AL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0411-2015Don't want to check this manually?
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