Recalls / Class II
Class IID-0945-2023
Product
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
- Affected lot / code info
- Lot # 1223047134, Use By: 09/21/2023
Why it was recalled
cGMP deviations: due to shipment of rejected units.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 183 bags
- Distribution pattern
- KY and NJ
Timeline
- Recall initiated
- 2023-07-20
- FDA classified
- 2023-07-26
- Posted by FDA
- 2023-08-02
- Terminated
- 2023-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0945-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.