Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
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 Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure…
Reason Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: TOLTERODINE TARTRATE ER…
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