Status
Terminated
Drug Enforcement D-005-2013
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Classification
Class III
Report Date
October 17, 2012
Termination Date
June 27, 2013
Product Information
- Product description
- 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.
- Product quantity
- 14,868 Bottles
- Reason for recall
- Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide & Puerto Rico
Location & Firm
- Recalling firm
- Actavis Mid Atlantic LLC
- Address
-
1877 Kawai Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-005-2013
- Event ID
- 62827
- Recall initiation date
- August 14, 2012
- Center classification date
- October 9, 2012
- Code info
- X111001, X111008, X111030, Exp 10/13
- More code info
- —