# FDA recall D-0601-2021

> **Mylan Institutional LLC** · Class III · drug recall initiated 2021-05-03.

## Product

Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0601-2021
- **Recalling firm:** Mylan Institutional LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-03
- **Report date:** 2021-06-09
- **Termination date:** 2022-10-18

- **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-0601-2021

## Citation

> AI Analytics. FDA recall D-0601-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0601-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*