FDAFDA · Food and drugs·Recall number D-006-2013
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
Published October 17, 2012 · Recall initiated: August 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Mid Atlantic LLC
- Distributor
- Nationwide & Puerto Rico
- Lot
- X110042, X110051, X110064, Exp 09/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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