Doxycycline Hyclate Tablets
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: DOXYCYCLINE HYCLATE, Capsule, 100 mg may have potentially been mislabeled as the following drug: RALOXIFENE HCL, Tablet, 60 mg, NDC 00002416530, Pedigree: W002644, EXP: 6/5/2014.
DOXYCYCLINE HYCLATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143314250.
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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