FDA-Drug2012-10-17Class III
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
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
19,980 Bottles
Manufactured in
1877 Kawai Rd, N/A, Lincolnton, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-006-2013Don't want to check this manually?
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