# FDA recall D-0955-2016

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2016-03-11.

## Product

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

## Reason for recall

CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0955-2016
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-11
- **Report date:** 2016-06-08
- **Termination date:** 2017-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0955-2016

## Citation

> AI Analytics. FDA recall D-0955-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0955-2016. Source: US FDA. Licensed CC0.

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