# FDA recall D-0858-2017

> **Strides Pharma INC** · Class III · drug recall initiated 2017-05-09.

## 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

- **Recall number:** D-0858-2017
- **Recalling firm:** Strides Pharma INC
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0858-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0858-2017. Source: US FDA. Licensed CC0.

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