Why it was recalled
Subpotency: Out-of-specification stability test result for low potency was obtained.
Product description
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Lot numbers, UPCs & expiration codes
Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
Where it was sold
Product was distributed to three hospitals in MO & LA.
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-0147-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 20, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 4,843 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0147-2021, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 86802
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
- Postal code
- 06095-1024
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0147-2021
- Classification
- Class III
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 4,843 syringes
- Termination date
- Jun 24, 2021
- Reason for recall
- Subpotency: Out-of-specification stability test result for low potency was obtained.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
- Distribution pattern
- Product was distributed to three hospitals in MO & LA.
- Recall initiation date
- Nov 20, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2020