Status
Ongoing
Drug Enforcement D-0632-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
May 24, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 2265 syringes
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Missouri only
Location & Firm
- Recalling firm
- Apollo Care, LLC
- Address
-
3801 Mojave Ct Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0632-2023
- Event ID
- 92348
- Recall initiation date
- May 2, 2023
- Center classification date
- May 18, 2023
- Code info
- Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023
- More code info
- —