Drug product
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
D-0632-2023
Product summary
- Firm
- Apollo Care, LLC
- Event
- Event 92348
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2265 syringes
- Official record key
drug-enforcement:D-0632-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023
Distribution pattern: Missouri only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility