# FDA recall D-0310-2020

> **Novitium Pharma LLC** · Class II · drug recall initiated 2019-10-25.

## Product

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520  NDC 70954-001-20

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0310-2020
- **Recalling firm:** Novitium Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-25
- **Report date:** 2019-11-20
- **Termination date:** 2021-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0310-2020

## Citation

> AI Analytics. FDA recall D-0310-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0310-2020. Source: US FDA. Licensed CC0.

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