Drug product
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
D-1491-2016
Product summary
- Event
- Event 74233
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,808 bottles
- Official record key
drug-enforcement:D-1491-2016
Official wording
Reason: 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.
Code information: Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification