Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, I...
FDA Recall #D-0325-2015 — Class II — December 23, 2014
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Recalling Firm
Zydus Pharmaceuticals USA Inc — Pennington, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
19,536 units
Distribution
Nationwide
Code Information
Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated