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Recall Observatory FDA recall evidence

Drug product

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

D-0507-2026

April 01, 2026

Class II

Product summary

Firm
Wells Pharma of Houston LLC
Event
Event 98694
Status
Ongoing
Classification
Class II
Quantity
4975 syringes
Official record key
drug-enforcement:D-0507-2026

Official wording

Reason: cGMP deviations.

Code information: 120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations