PROMETHAZINE DM SYRUP — Class II drug recall D-0411-2015
Terminated recall by Qualitest Pharmaceuticals, reported 2015-03-18, distributed nationwide. Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
| Recall number | D-0411-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2015-02-23 |
| Classified | 2015-03-12 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2016-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 972 bottles |
| Reason classes | specification failure |
| NDC | 00603-1586-58 |
| Lot numbers | 0000001099, 03/16 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0411-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.