Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare...
FDA Recall #D-0299-2015 — Class II — November 26, 2014
Product Description
Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
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
58,920 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: MP2137, MP2138, MP2139, Exp 01/16; MP3614, Exp 03/16; MP5611, MP5613, Exp 05/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated