Class II · Moderate risk Ongoing
Doxycycline Hyclate Tablets
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
DOXYCYCLINE MONOHYDRATE Capsule
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD67992_4, EXP: 5/28/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD52778_4, EXP: 5/20/2014.
What was recalled
DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-588-2014
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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