FDAFDA · Food and drugs·Recall number D-0325-2015
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
Published December 31, 2014 · Recall initiated: December 23, 2014
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 Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BENZONATATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- Nationwide
- Lot
- Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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