Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-006-2013·Announced 2012-10-17

Actavis Recalls Prometh VC with Codeine Cough Syrup Due to Stability Issues

Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup because specific lots do not meet room temperature stability specifications for an unknown degradant.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The hazard involves an unknown degradant affecting stability, which fits the criteria for a moderate severity voluntary precautionary recall without reported injuries.

Plain-English summary

Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup, CV. The affected product is a prescription cough syrup containing codeine phosphate, promethazine hydrochloride, and phenylephrine hydrochloride. The recall involves 19,980 one-pint bottles (473mL) distributed nationwide and in Puerto Rico.

The recall was initiated because the recalled lots do not meet the room temperature stability specification for an unknown degradant. The affected lots have expiration dates of 09/13 and lot codes X110042, X110051, or X110064.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments.

The recalled product

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…
Manufacturer: Actavis Mid Atlantic LLC
Category: Drug — Cough Syrup
Hazard: impurities
degradation-products
Affected units: 19,980

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

X110042
X110051
X110064
Exp 09/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Actavis Mid Atlantic LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Actavis Mid Atlantic LLC

See all →

Low
Actavis Recalls Prometh VC Plain Due to Unknown Degradant
FDA (Drugs) · 2012-10-17

Same hazard · impurities