Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
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: Stability testing found that the lot did not meet dissolution specifications.
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.
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