Recall: D-0858-2017

Class III - Minor Violations

Class IIIClassification

2017-05-09Initiated

TerminatedStatus

Strides Pharma INCFirm

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

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

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.