Why it was recalled
cGMP deviations: due to shipment of rejected units.
Product description
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Lot numbers, UPCs & expiration codes
Lot # 1223047134, Use By: 09/21/2023
Where it was sold
KY and NJ
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-0945-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 20, 2023
- FDA report date
- Aug 2, 2023
- Quantity
- 183 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0945-2023, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 92737
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot # 1223047134, Use By: 09/21/2023
- Postal code
- 06095-1024
- Report date
- Aug 2, 2023
- Product type
- Drugs
- Recall number
- D-0945-2023
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 183 bags
- Termination date
- Sep 21, 2023
- Reason for recall
- cGMP deviations: due to shipment of rejected units.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
- Distribution pattern
- KY and NJ
- Recall initiation date
- Jul 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2023