Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Prometh VC with Codeine Cough Syrup Recalled by Actavis Mid Atlantic LLC Due to Impurities/Degradation Products: Recalled lots do not meet room...

Date: August 14, 2012
Company: Actavis Mid Atlantic LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Actavis Mid Atlantic LLC directly.

Affected 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

Quantity: 19,980 Bottles

Why Was This Recalled?

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Actavis Mid Atlantic LLC

Actavis Mid Atlantic LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report