FDA recall D-0858-2017

Product

Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06

Reason for recall

Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2017-05-09

Report date

2017-05-31

Termination date

2017-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0858-2017