Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
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 Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
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