Actavis Mid Atlantic LLC Recalls

FDA
2
Total Recalls
1
Agencies
Oct 2012
First Recall
Oct 2012
Latest Recall
Sort: Newest first Highest severity

Showing 1-2 of 2 recalls

FDA

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.

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
FDA

Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; 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 0472-1629-16

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.