Prometh VC with Codeine (Actavis) – Stability Degradation (2012)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Actavis Mid Atlantic LLC
Lot Codes / Batch Numbers
X110042, X110051, X110064, Exp 09/13
Products Sold
X110042, X110051, X110064, Exp 09/13
Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hyd due to Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026