CGMP Deviations
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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BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.. Generic: BENZALKONIUM CHLORIDE; Brand: MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC. Reason: CGMP Deviations. Classification: Class II. Quantity: N/A. Distribution: Nationwide within the United States
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Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Defective container; inadequately sealed blister packaging.