Drug product
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
D-0646-2023
Product summary
- Firm
- Apollo Care, LLC
- Event
- Event 92348
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 308 bags
- Official record key
drug-enforcement:D-0646-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023
Distribution pattern: Missouri only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility