# FDA recall D-246-2013

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2013-03-12.

## Product

Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY  10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 0555-9123-66.

## Reason for recall

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-246-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-12
- **Report date:** 2013-04-17
- **Termination date:** 2014-01-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-246-2013

## Citation

> AI Analytics. FDA recall D-246-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-246-2013. Source: US FDA. Licensed CC0.

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