Nationwide recall of Dukal BZK Antiseptic Towelettes due to CGMP deviations. The products are manufactured for Dukal, LLC in Ronkonkoma, NY and distributed across the United States. Stop using immediately and contact ACME United Corporation 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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Model numbers: MN31621; MN14522; MN15522; MN28122; MN31522; MN04223; MN06023; MN17223; MN25123; MN33123; MN33523. 1000 packs per case. NDC 65517-0004-1. Manufactured for: Dukal, LLC. Made in USA. Distribution: Nationwide in the United States. Case quantity: 1000 packs per case. Expires on various dates listed below: Exp. Oct 2026; Exp. Apr 2027; Exp. Sept 2027; Exp. Feb 2028; Exp. May 2028; Exp. Aug 2028; Exp. Nov 2028.
The recall is due to CGMP deviations in manufacturing. The exact defect details are not described in the recall notice. Consumers should treat this as a quality-control issue that could affect product consistency and safety.
1. Stop using the product immediately. 2. Contact ACME United Corporation or your healthcare provider for guidance. 3. Follow any instructions in the recall notice or on the FDA enforcement report. 4. If directed, quarantine and return affected lots per supplier guidance. 5. Monitor for updates from FDA and the recalling company.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0360-2026. Hours and direct phone details are not provided in the notice.
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