FDA recall D-0411-2015

Qualitest Pharmaceuticals · Class II · 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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-02-23
Report date: 2015-03-18
Termination date: 2016-07-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0411-2015