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

Recall Number: D-0858-2017

Firm: Strides Pharma INC

Classification: Class III

Status: Terminated

Report Date: 20170531

Initiation Date: 20170509

Termination Date: 20171222

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

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