# FDA recall D-0793-2020

> **H J Harkins Company Inc dba Pharma Pac** · Class II · drug recall initiated 2020-01-06.

## Product

Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac  Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Distributed to Physicians in the following states: CA, FL, NC, and SC.

## Key facts

- **Recall number:** D-0793-2020
- **Recalling firm:** H J Harkins Company Inc dba Pharma Pac
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-06
- **Report date:** 2020-01-29
- **Termination date:** 2023-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grover Beach, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2020

## Citation

> AI Analytics. FDA recall D-0793-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0793-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*