Recalls / Class II
Class IID-1443-2019
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
- Affected lot / code info
- 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, EXP Jun-20; M815082, M815083, M815084, M815085, M815086 EXP Aug-20; M900476, M900477, M900478, M900479, M900481, Dec-20;
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 143,184 90-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-06
- FDA classified
- 2019-07-01
- Posted by FDA
- 2019-06-26
- Terminated
- 2021-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1443-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.