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
Reported: June 26, 2019 Initiated: May 6, 2019 #D-1452-2019
Product Description
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
Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 47,664 90-count bottles
- Distribution
- Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 47,664 90-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-1452-2019.
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