PROMETHAZINE VC WITH CODEINE SYRUP — Class III drug recall D00432-2015
Terminated recall by Qualitest Pharmaceuticals, reported 2015-04-15, distributed nationwide. Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at
| Recall number | D00432-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2015-03-25 |
| Classified | 2015-04-06 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2016-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 36,732 units |
| Reason classes | specification failure |
| NDC | 00603-1588-54, 00603-1588-58 |
| Lot numbers | 0000002247, L063B14A, L073D14A, L073D14B |
| Expiration dates | 2015-05-31, 2015-07-31, 2016-03-31 |
Product
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.
Reason for recall
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
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/D00432-2015. 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.