Recalls / Class II
Class IID-0192-2021
Product
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
- Affected lot / code info
- Lot # 1220022911, BUD 1/18/2021; 1220023092, BUD 1/25/2021 & 1220023247, BUD 1/27/2021.
Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 996 syringes
- Distribution pattern
- Product was distributed to hospitals nationwide.
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2021-01-07
- Posted by FDA
- 2021-01-13
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0192-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.