# FDA recall D-1046-2016

> **Sandoz, Inc** · Class III · drug recall initiated 2016-05-02.

## Product

Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz  Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

## Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1046-2016
- **Recalling firm:** Sandoz, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-02
- **Report date:** 2016-06-29
- **Termination date:** 2017-08-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2016

## Citation

> AI Analytics. FDA recall D-1046-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1046-2016. Source: US FDA. Licensed CC0.

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