FDA recall D-0289-2015

Product

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01

Reason for recall

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Distribution

US Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-09-24

Report date

2014-12-10

Termination date

2017-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0289-2015