Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Product description
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Lot numbers, UPCs & expiration codes
Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015
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-1139-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 13, 2015
- FDA report date
- Jun 24, 2015
- Quantity
- 14,649 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-1139-2015, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71378
- Address
- 465 Industrial Way W
- Code information
- Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015
- Postal code
- 07724-2209
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1139-2015
- Classification
- Class III
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Product quantity
- 14,649 Cartons
- Termination date
- Apr 6, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2015