Recalls / Class II
Class IID-1491-2016
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
- Brand name
- Bromocriptine Mesylate
- Generic name
- Bromocriptine Mesylate
- Active ingredient
- Bromocriptine Mesylate
- Route
- Oral
- NDC
- 68382-110
- FDA application
- ANDA078899
- Affected lot / code info
- Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
Why it was 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.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 14,808 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2016-05-09
- FDA classified
- 2016-09-02
- Posted by FDA
- 2016-09-14
- Terminated
- 2018-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1491-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.