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Recall Observatory FDA recall evidence

Drug product

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

D-0508-2026

April 01, 2026

Class II

Product summary

Firm
Wells Pharma of Houston LLC
Event
Event 98694
Status
Ongoing
Classification
Class II
Quantity
50 syringes
Official record key
drug-enforcement:D-0508-2026

Official wording

Reason: cGMP deviations.

Code information: Lot 020226202150202, Exp Date 05/05/2026.

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations