FDA-Drug2025-11-26Class IICHEMICAL
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
Hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
36,624 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2026Want us to check the next one for you?
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