Drug 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.
D-005-2013
Product summary
- Event
- Event 62827
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,868 Bottles
- Official record key
drug-enforcement:D-005-2013
Official wording
Reason: Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Code information: X111001, X111008, X111030, Exp 10/13
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Unknown
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.