Drug product
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
D-0635-2023
Product summary
- Firm
- Apollo Care, LLC
- Event
- Event 92348
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2040 syringes
- Official record key
drug-enforcement:D-0635-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: AC-016627, Exp. Date 06/17/2023; AC-016635, Exp. Date 07/08/2023; AC-016662, Exp. Date 09/30/2023
Distribution pattern: Missouri only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility