# FDA recall D-1328-2015

> **Mylan Institutional LLC** · Class I · drug recall initiated 2015-03-18.

## Product

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY  10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, NDC 67457-467-99.

## Reason for recall

Presence of Particulate Matter

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1328-2015
- **Recalling firm:** Mylan Institutional LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-18
- **Report date:** 2015-08-19
- **Termination date:** 2016-06-29

- **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-1328-2015

## Citation

> AI Analytics. FDA recall D-1328-2015. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1328-2015. Source: US FDA. Licensed CC0.

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