Drug product
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
D-0159-2026
Product summary
- Event
- Event 97847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36,624 bottles
- Official record key
drug-enforcement:D-0159-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Code information: Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification