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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: X111001, X111008, X111030, Exp 10/13
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 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.
Product Codes/Lot Numbers:
X111001, X111008, X111030, Exp 10/13
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-005-2013
Related Recalls
Class I - Dangerous
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.