# FDA recall D-0974-2022

> **Strides Pharma Inc.** · Class II · drug recall initiated 2022-05-18.

## Product

Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816.    90 film coated tablets NDC 64380-935-05  1000 film coated tablets NDC 64380-935-08

## Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0974-2022
- **Recalling firm:** Strides Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-18
- **Report date:** 2022-06-08
- **Termination date:** 2023-10-20

- **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-0974-2022

## Citation

> AI Analytics. FDA recall D-0974-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0974-2022. Source: US FDA. Licensed CC0.

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