Recalls / Class II
Class IID-0411-2015
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.
- Affected lot / code info
- Lot #: 0000001099; Exp. 03/16
Why it was recalled
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 972 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-23
- FDA classified
- 2015-03-12
- Posted by FDA
- 2015-03-18
- Terminated
- 2016-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0411-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.