# FDA recall D-0777-2021

> **Granules USA, Inc.** · Class II · drug recall initiated 2021-08-11.

## Product

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules  India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village,   Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043,  Telangana, INDIA. NDC 62207-762-36

## Reason for recall

CGMP Deviations

## Distribution

NY

## Key facts

- **Recall number:** D-0777-2021
- **Recalling firm:** Granules USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-11
- **Report date:** 2021-09-08
- **Termination date:** 2023-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2021

## Citation

> AI Analytics. FDA recall D-0777-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0777-2021. Source: US FDA. Licensed CC0.

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