Reported Sep 14, 2016 · Terminated
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd.,…
Zydus Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only
- Manufactured byCadila Healthcare ltd., Ahmedabad
- India Distributed byZydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
- Lot codes and dates
Lot # MP993Exp10/16MR2704Exp 02/17MR6851MR8100Exp 07/17 and MR1210Exp 12/17
- Amount recalled
- 14,808 bottles
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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