# FDA recall D-1102-2018

> **RemedyRepack Inc.** · Class II · drug recall initiated 2018-08-10.

## Product

Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701,   NDC 61786-0793-19

## Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Product was distributed to three customers in FL and VA.

## Key facts

- **Recall number:** D-1102-2018
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-10
- **Report date:** 2018-08-22
- **Termination date:** 2018-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1102-2018

## Citation

> AI Analytics. FDA recall D-1102-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1102-2018. Source: US FDA. Licensed CC0.

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