# FDA recall D-1125-2017

> **Morton Grove Pharmaceuticals, Inc.** · Class II · drug recall initiated 2017-08-10.

## Product

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ  07054, NDC 60432-065-00.

## Reason for recall

Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-1125-2017
- **Recalling firm:** Morton Grove Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-10
- **Report date:** 2017-09-06
- **Termination date:** 2018-09-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1125-2017

## Citation

> AI Analytics. FDA recall D-1125-2017. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-1125-2017. Source: US FDA. Licensed CC0.

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