Pramipexole Dihydrochloride Tablets 0 recalled over manufacturing violations
- Recall date
- May 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmeda…
- Recall number
- D-1445-2019
- FDA classification
- Class II
- Brand / firm
- Zydus Pharmaceuticals USA Inc
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
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