# FDA recall D-1515-2016

> **West-Ward Pharmaceuticals Corp.** · Class III · drug recall initiated 2016-08-18.

## Product

Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only,  Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

## Reason for recall

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1515-2016
- **Recalling firm:** West-Ward Pharmaceuticals Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-18
- **Report date:** 2016-09-28
- **Termination date:** 2017-09-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1515-2016

## Citation

> AI Analytics. FDA recall D-1515-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1515-2016. Source: US FDA. Licensed CC0.

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