Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
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 Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
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