# FDA recall D-0038-2016

> **Ohm Laboratories, Inc.** · Class III · drug recall initiated 2015-07-28.

## Product

Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL  60015

## Reason for recall

Superpotent Drug: Out Of Specification (OOS) result for Assay.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0038-2016
- **Recalling firm:** Ohm Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-28
- **Report date:** 2015-10-21
- **Termination date:** 2016-10-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0038-2016

## Citation

> AI Analytics. FDA recall D-0038-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0038-2016. Source: US FDA. Licensed CC0.

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