FDA Drug recall D-0411-2015
PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Prome…
- FDA Drug
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Prome… by Qualitest Pharmaceuticals, citing presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0411-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-23 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qualitest Pharmaceuticals |
| Distribution | US |
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
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Identifiers
| code_info | Lot #: 0000001099; Exp. 03/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0411-2015%22
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