# FDA recall D-1110-2018

> **A-S Medication Solutions LLC.** · Class II · drug recall initiated 2018-07-17.

## Product

Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0

## Reason for recall

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

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1110-2018
- **Recalling firm:** A-S Medication Solutions LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-07-17
- **Report date:** 2018-08-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Libertyville, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1110-2018

## Citation

> AI Analytics. FDA recall D-1110-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1110-2018. Source: US FDA. Licensed CC0.

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