Class II · Moderate risk Ongoing
Doxycycline Hyclate Tablets
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Doxycycline
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
What was recalled
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
- Recalling firm
- Galderma Laboratories, L.P.
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1031-2016
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.
Other Doxycycline recalls
See all
Class II · Moderate risk Terminated
Doxycycline
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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