The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-005-2013·Announced 2012-10-17

Actavis Recalls Prometh VC Plain Due to Unknown Degradant

Actavis Mid Atlantic LLC is recalling Prometh VC Plain bottles because they do not meet 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Actavis Mid Atlantic LLC is recalling 14,868 bottles of Prometh VC Plain, a prescription cough and cold medication. The product is available in one-pint (473mL) bottles and contains Promethazine Hydrochloride 6.25mg and Phenylephrine Hydrochloride 5mg per 5mL. The recall is due to the presence of an unknown degradant that causes the recalled lots to fail room temperature stability specifications.

The affected product was distributed nationwide and in Puerto Rico. The specific lot codes involved are X111001, X111008, and X111030, all with an expiration date of 10/13. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot codes and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or distributor for disposal or replacement in accordance with standard recall procedures.

The recalled product

Product
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.
Manufacturer
Actavis Mid Atlantic LLC
Category
Drug — Prescription Cough and Cold
Hazard
Affected units
14,868

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)

  • X111001
  • X111008
  • X111030
  • Exp 10/13

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 →

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