Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by cleaning failures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg, 90-count bottles. The recall involves 143,184 bottles distributed nationwide in the USA. The product is manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure. The affected lots include M714176, M714177, M714917, M714918, M715594, M715595, M802190, M802191, M808673, M811125, M811126, M811127, M811128, M811129, M815082, M815083, M815084, M815085, M815086, M900476, M900477, M900478, M900479, and M900481, with expiration dates ranging from October 2019 to December 2020.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
- 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 (20)
- Lot: M714176
- M714177
- EXP Oct-19
- M714917
- EXP Nov-19
- M714918
- M715594
- M715595
- EXP Dec-19
- M802190
- EXP Jan-20
- M802191
- EXP Feb-20
- M808673
- EXP May-20
- M811125
- M811126
- M811127
- M811128
- M811129
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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