# FDA recall D-1012-2020

> **Perrigo Company PLC** · Class II · drug recall initiated 2019-10-23.

## Product

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65

## Reason for recall

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1012-2020
- **Recalling firm:** Perrigo Company PLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-23
- **Report date:** 2020-03-25
- **Termination date:** 2020-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allegan, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1012-2020

## Citation

> AI Analytics. FDA recall D-1012-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1012-2020. Source: US FDA. Licensed CC0.

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