FDA Drug recall D-005-2013
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only…
- FDA Drug
- Class III
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class III recall of Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only… by Actavis Mid Atlantic, citing impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-005-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-14 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Mid Atlantic |
| Distribution | US |
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
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Identifiers
| code_info | X111001, X111008, X111030, Exp 10/13 |
|---|
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-005-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.