🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: August 14, 2012 Actavis Mid Atlantic Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    X110042, X110051, X110064, Exp 09/13
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Actavis Mid Atlantic LLC
Reason for Recall:
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

X110042, X110051, X110064, Exp 09/13

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-006-2013

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