# FDA recall D-0276-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2021-02-10.

## Product

Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-5140-01.

## Reason for recall

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

## Distribution

Product was distributed nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0276-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-10
- **Report date:** 2021-03-03
- **Termination date:** 2024-05-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2021

## Citation

> AI Analytics. FDA recall D-0276-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0276-2021. Source: US FDA. Licensed CC0.

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