Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination Risk
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1.5 mg due to cross-contamination caused by cleaning failures.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential adverse health consequences from contamination.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1.5 mg, 90-count bottles (NDC 68382-200-16). The recall involves 47,664 bottles distributed nationwide in the USA. The affected lots are M713435, M713436 (EXP Sep-19), M714191 (EXP Oct-19), M808185, M808184, M808186 (EXP May-20), and M817634, M817635 (EXP Nov-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, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if necessary.
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
- 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 (4)
- Lots: M713435 M713436 EXP Sep-19
- M714191 EXP Oct-19
- M808185 M808184 M808186 EXP May-20
- M817634 M817635 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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