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Recall Observatory FDA recall evidence

Drug product

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02

D-0369-2026

January 20, 2026

Class II

Product summary

Firm
ACME UNITED CORPORATION
Event
Event 98291
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0369-2026

Official wording

Reason: CGMP Deviations

Code information: Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations