Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited…
Reason Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 50 mg may have potentially been mislabeled as the following drug: SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W002979, EXP: 6/11/2014.
CHLORTHALIDONE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378021301.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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