# FDA recall D-0639-2022

> **Macleods Pharma Usa Inc** · Class II · drug recall initiated 2022-02-16.

## Product

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.

## Reason for recall

cGmp Deviations

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0639-2022
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-16
- **Report date:** 2022-03-09
- **Termination date:** 2023-10-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0639-2022

## Citation

> AI Analytics. FDA recall D-0639-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0639-2022. Source: US FDA. Licensed CC0.

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