# FDA recall D-0131-2023

> **Accord Healthcare, Inc.** · Class I · drug recall initiated 2022-11-29.

## Product

Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05

## Reason for recall

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0131-2023
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-11-29
- **Report date:** 2023-01-25
- **Termination date:** 2024-02-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0131-2023

## Citation

> AI Analytics. FDA recall D-0131-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0131-2023. Source: US FDA. Licensed CC0.

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