FDAFDA · Food and drugs·Recall number D-005-2013
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.
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
- X111001, X111008, X111030, Exp 10/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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