Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
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 Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Reason Defective Container; packets were found to be either empty or partially full.
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of Foreign substance - potential presence of metal particulate matter
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