Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by a cleaning failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (cross-contamination) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottles. The recall involves 204 bottles distributed nationwide in the USA. The affected lots are M714919 (EXP Dec-19), M815081 (EXP Aug-20), and M900475 (EXP Dec-20).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for guidance on alternative treatment options. The product is prescription-only and was distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: M714919
- EXP Dec-19
- M815081
- EXP Aug-20
- M900475
- EXP Dec-20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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