# FDA recall D-0748-2022

> **Mylan Pharmaceuticals Inc** · Class II · drug recall initiated 2022-04-01.

## Product

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.

## Reason for recall

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0748-2022
- **Recalling firm:** Mylan Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-01
- **Report date:** 2022-04-13
- **Termination date:** 2023-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0748-2022

## Citation

> AI Analytics. FDA recall D-0748-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0748-2022. Source: US FDA. Licensed CC0.

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