Why it was recalled
CGMP Deviations
Product description
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Lot numbers, UPCs & expiration codes
Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22
Where it was sold
Product was distributed nationwide within the United States
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-0830-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 25, 2022
- FDA report date
- May 11, 2022
- Quantity
- 424 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0830-2022, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 90080
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22
- Postal code
- 06095-1024
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0830-2022
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 424 bags
- Termination date
- Sep 9, 2022
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
- Distribution pattern
- Product was distributed nationwide within the United States
- Recall initiation date
- Apr 25, 2022
- Initial firm notification
- Letter
- Center classification date
- May 2, 2022