# FDA recall D-0475-2017

> **Apotex Inc.** · Class II · drug recall initiated 2017-02-03.

## Product

CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0

## Reason for recall

Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

## Distribution

Distributed Nationwide

## Key facts

- **Recall number:** D-0475-2017
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-03
- **Report date:** 2017-03-01
- **Termination date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North York, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2017

## Citation

> AI Analytics. FDA recall D-0475-2017. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/D-0475-2017. Source: US FDA. Licensed CC0.

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