🔍 RecallPedia

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.

Class I - Dangerous
💊 Drugs Recalled: February 16, 2015 West-Ward Pharmaceutical Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
  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:
West-Ward Pharmaceutical Corporation
Reason for Recall:
Failed Impurities/Degradation Specifications; 12 month stability testing.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.

Product Codes/Lot Numbers:

Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0420-2015

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