Recalls / Class II
Class IID-1843-2019
Product
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
- Affected lot / code info
- Lot #: 1219010961, Exp. 10/24/2019
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 922 syringes
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-08-16
- FDA classified
- 2019-08-26
- Posted by FDA
- 2019-08-28
- Terminated
- 2019-10-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1843-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.