Drug 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.
D-0411-2015
Product summary
- Event
- Event 70598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 972 bottles
- Official record key
drug-enforcement:D-0411-2015
Official wording
Reason: Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Code information: Lot #: 0000001099; Exp. 03/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulates