Status
Ongoing
Drug Enforcement D-0635-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
May 24, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 2040 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-0635-2023
- Event ID
- 92348
- Recall initiation date
- May 2, 2023
- Center classification date
- May 18, 2023
- Code info
- Lot #: AC-016627, Exp. Date 06/17/2023; AC-016635, Exp. Date 07/08/2023; AC-016662, Exp. Date 09/30/2023
- More code info
- —