Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 1 mg due to cross-contamination caused by a cleaning failure.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, aligning with a moderate severity rating for a CGMP deviation involving cross-contamination.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottles. The recall involves 113,304 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 agency has classified this recall as Class II.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The affected lots include M714186 through M714188 (EXP Oct-19), M714903 through M714905 and M715586 through M715587 (EXP Nov-19), M801441 through M801445 (EXP Dec-19), M811152 through M811156 and M814298 (EXP Jul-20), M814299 through M814302 (EXP Aug-20), and M818136 through M818140 (EXP Nov-20).
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
- 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 (6)
- Lots: M714186 M714187 M714188 EXP Oct-19
- M714903 M714904 M714905 M715586 M715587 EXP Nov-19
- M801441 M801442 M801443 M801444 M801445 EXP Dec-19
- M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20
- M814299 M814300 M814301 M814302 EXP Aug-20
- M818136 M818137 M818138 M818139 M818140 EXP Nov-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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