# FDA recall D-0615-2023

> **Astral SteriTech Private Ltd.** · Class II · drug recall initiated 2023-05-15.

## Product

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0615-2023
- **Recalling firm:** Astral SteriTech Private Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-15
- **Report date:** 2023-05-24
- **Termination date:** 2024-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vadodara, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0615-2023

## Citation

> AI Analytics. FDA recall D-0615-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0615-2023. Source: US FDA. Licensed CC0.

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