Recalls / Class II
Class IID-0831-2022
Product
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
- Affected lot / code info
- Lot #: 1222035839, Exp. Date 09-Aug-22
Why it was recalled
CGMP Deviations
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
- 30 bags
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2022-04-25
- FDA classified
- 2022-05-02
- Posted by FDA
- 2022-05-11
- Terminated
- 2022-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0831-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.