# FDA recall D-1022-2018

> **H J Harkins Company Inc dba Pharma Pac** · Class II · drug recall initiated 2018-07-26.

## Product

Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09.      Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with  343  on one side and  HH  on the other side.

## Reason for recall

Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Product was distributed to a physician's office.

## Key facts

- **Recall number:** D-1022-2018
- **Recalling firm:** H J Harkins Company Inc dba Pharma Pac
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-26
- **Report date:** 2018-08-08
- **Termination date:** 2019-01-18

- **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-1022-2018

## Citation

> AI Analytics. FDA recall D-1022-2018. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1022-2018. Source: US FDA. Licensed CC0.

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