Class III
Terminated
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
- Company
- Actavis Mid Atlantic Llc
- Recall Initiated
- August 14, 2012
- Posted
- October 17, 2012
- Recall Number
- D-006-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 19,980 Bottles
- Firm Location
- Lincolnton, NC, United States
Reason for Recall
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Distribution
Nationwide & Puerto Rico
Lot / Code Info
X110042, X110051, X110064, Exp 09/13
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