Class II
Terminated
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
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- May 9, 2016
- Posted
- September 14, 2016
- Recall Number
- D-1491-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,808 bottles
- Firm Location
- Pennington, NJ, United States
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.
Distribution
US Nationwide
Lot / Code Info
Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
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