D-1843-2019 Class II Terminated
FDA drug recall D-1843-2019 was initiated by SCA Pharmaceuticals, LLC on August 16, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility. The recall status is terminated (terminated October 15, 2019). Affected quantity: 922 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2019
- Initiation Date
- August 16, 2019
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 922 syringes
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: 1219010961, Exp. 10/24/2019