# FDA recall D-0753-2022

> **Sandoz, Inc** · Class II · drug recall initiated 2022-03-21.

## Product

Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.

## Reason for recall

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0753-2022
- **Recalling firm:** Sandoz, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-21
- **Report date:** 2022-04-13
- **Termination date:** 2023-08-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0753-2022

## Citation

> AI Analytics. FDA recall D-0753-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0753-2022. Source: US FDA. Licensed CC0.

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