# FDA recall D-0822-2018

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class II · drug recall initiated 2018-05-01.

## Product

Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20

## Reason for recall

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0822-2018
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-01
- **Report date:** 2018-05-30
- **Termination date:** 2021-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0822-2018

## Citation

> AI Analytics. FDA recall D-0822-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0822-2018. Source: US FDA. Licensed CC0.

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