# FDA recall D-0005-2017

> **Teva North America** · Class III · drug recall initiated 2016-08-05.

## Product

Claravis (isotretinoin capsules USP), 10mg,  packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0005-2017
- **Recalling firm:** Teva North America
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-05
- **Report date:** 2016-10-12
- **Termination date:** 2017-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2017

## Citation

> AI Analytics. FDA recall D-0005-2017. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0005-2017. Source: US FDA. Licensed CC0.

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