Recalls / Class II
Class IID-0632-2023
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
- Affected lot / code info
- Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Apollo Care, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3801 Mojave Ct Ste 101, N/A, Columbia, Missouri 65202-4042
Distribution
- Quantity
- 2265 syringes
- Distribution pattern
- Missouri only
Timeline
- Recall initiated
- 2023-05-02
- FDA classified
- 2023-05-18
- Posted by FDA
- 2023-05-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0632-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.