Pramipexole Dihydrochloride Tablets 1.5 mg 90-count recall: CGMP Deviations
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
Why was Pramipexole Dihydrochloride Tablets 1.5 mg 90-count recalled?
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: M713435 M713436 EXP Sep-19; M714191 EXP Oct-19; M808185 M808184 M808186 EXP May-20; M817634 M817635 EXP Nov-20
- 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
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Quantity
- 47,664 90-count bottles
- Distribution
- Nationwide in the USA
- Recall date
- June 26, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)