# FDA recall D-0648-2020

> **Appco Pharma LLC** · Class II · drug recall initiated 2020-01-07.

## Product

Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.

## Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

## Distribution

Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.

## Key facts

- **Recall number:** D-0648-2020
- **Recalling firm:** Appco Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-07
- **Report date:** 2020-01-15
- **Termination date:** 2020-04-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2020

## Citation

> AI Analytics. FDA recall D-0648-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0648-2020. Source: US FDA. Licensed CC0.

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