D-006-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 17, 2012
- Initiation Date
- August 14, 2012
- Termination Date
- June 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,980 Bottles
Product Description
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
Reason for Recall
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Distribution Pattern
Nationwide & Puerto Rico
Code Information
X110042, X110051, X110064, Exp 09/13