FDAFDA · Food and drugs·Recall number D-1491-2016
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
Published September 14, 2016 · Recall initiated: May 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BROMOCRIPTINE MESYLATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- US Nationwide
- UPC
- 0368382110015
- Lot
- Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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