Prometh VC Plain — Class III drug recall D-005-2013
Terminated recall by Actavis Mid Atlantic LLC, reported 2012-10-17, distributed nationwide. Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknow
| Recall number | D-005-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Mid Atlantic LLC, Lincolnton, NC, United States |
| Recall initiated | 2012-08-14 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 14,868 bottles |
| Reason classes | specification failure |
| NDC | 00472-1628-16 |
Product
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Reason for recall
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
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-005-2013. 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.