FDA-Drug2012-10-17Class III
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.
Actavis Mid Atlantic LLC
Hazard
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Sold states
Nationwide & Puerto Rico
Affected count
14,868 Bottles
Manufactured in
1877 Kawai Rd, N/A, Lincolnton, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-005-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief