# FDA recall D-0375-2019

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-01-02.

## Product

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

## Reason for recall

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0375-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-02
- **Report date:** 2019-01-16
- **Termination date:** 2020-06-26

- **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-0375-2019

## Citation

> AI Analytics. FDA recall D-0375-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0375-2019. Source: US FDA. Licensed CC0.

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