Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0635-2023

May 02, 2023

Class II

Product summary

Firm
Apollo Care, LLC
Event
Event 92348
Status
Ongoing
Classification
Class II
Quantity
2040 syringes
Official record key
drug-enforcement:D-0635-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: AC-016627, Exp. Date 06/17/2023; AC-016635, Exp. Date 07/08/2023; AC-016662, Exp. Date 09/30/2023

Distribution pattern: Missouri only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility