Dynarex recalled 100-pack BZK Antiseptic Towelettes sold nationwide after FDA enforcement cited CGMP deviations. The recall covers multiple lots, including Lot 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027 and Exp. Date Jun 2027. Consumers should stop using the product immediately and contact ACME UNITED CORPORATION or their healthcare provider for guidance.
CGMP Deviations
Consumers and healthcare providers should stop using this product immediately. Contact ACME UNITED CORPORATION or your healthcare provider for guidance. Notification method: Letter
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Brand: Dynarex; Product: BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7; NDC 67777-245-01; Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA; Sold nationwide in the United States; Recall Date: 2026-01-20; Status: ACTIVE; Model/lot numbers: Lot 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027, 53518, Exp. Date Jun 2027.
The recall centers on CGMP deviations at the manufacturing level. The defect involves manufacturing process deviations that could affect product quality. There is no specific injury tied to the notice, but the failure to meet CGMP standards raises potential safety concerns for users.
1. Stop using the product immediately. 2. Contact ACME UNITED CORPORATION or your healthcare provider for guidance. 3. Monitor for recall updates and follow any directions issued in the official notification.
Recall notice and guidance are posted by the FDA enforcement page. Consumers should refer to the recall number D-0375-2026 and contact ACME UNITED CORPORATION for instructions. For more details, visit the FDA recall page linked in the notice.
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