# FDA recall D-1019-2020

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

## Product

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB:  37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02

## Reason for recall

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1019-2020
- **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-1019-2020

## Citation

> AI Analytics. FDA recall D-1019-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1019-2020. Source: US FDA. Licensed CC0.

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