Pramipexole Dihydrochloride Tablets 0.25 mg recall: CGMP Deviations
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
Why was Pramipexole Dihydrochloride Tablets 0.25 mg 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: M706803, EXP Jun-19; M713438, EXP Oct-19; M801704, EXP Jan-20; M808306, EXP Jun-20; M812484, EXP Aug-20; M820264, EXP Dec-20
- Product
- Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Quantity
- 3,156 1000-count bottles
- Distribution
- Nationwide in the USA
- Recall date
- June 26, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)