Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
Reported: June 26, 2019 Initiated: May 6, 2019 #D-1442-2019
Product Description
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 204 1000-count bottles
- Distribution
- Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 204 1000-count bottles.
Why was this product recalled? ▼
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2019. Severity: Moderate. Recall number: D-1442-2019.
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