Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 50 mg may have potentially been mislabeled as the following drug: MINOXIDIL, Tablet, 2.5 mg, NDC 00591564201, Pedigree: AD52778_49, EXP: 5/20/2014.
MINOCYCLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569401.
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: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason Failed Dissolution Specifications: low out of specification results for dissolution testing.
Reason Failed Dissolution Specifications:
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