Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0420-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 16, 2015
- FDA report date
- Apr 1, 2015
- Quantity
- 445,475 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corporation
Original FDA data
Every field from FDA enforcement report D-0420-2015, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70548
- Address
- 2 Esterbrook Ln
- Code information
- Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
- Postal code
- 08003-4002
- Report date
- Apr 1, 2015
- Product type
- Drugs
- Recall number
- D-0420-2015
- Classification
- Class III
- Recalling firm
- West-Ward Pharmaceutical Corporation
- Product quantity
- 445,475 Vials
- Termination date
- Jul 26, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications; 12 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 16, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2015