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Recall Observatory FDA recall evidence

Drug product

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

D-0506-2026

April 01, 2026

Class II

Product summary

Firm
Wells Pharma of Houston LLC
Event
Event 98694
Status
Ongoing
Classification
Class II
Quantity
150 syringes
Official record key
drug-enforcement:D-0506-2026

Official wording

Reason: cGMP deviations.

Code information: Lot 022326203650432; Exp Date 06/25/2026

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations