Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Reported: September 14, 2016 Initiated: May 9, 2016 #D-1491-2016
Product Description
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Reason for Recall
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 14,808 bottles
- Distribution
- US Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 14,808 bottles.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2016. Severity: Moderate. Recall number: D-1491-2016.
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