# FDA recall D-1148-2015

> **Actavis Inc** · Class III · drug recall initiated 2015-06-04.

## Product

Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28

## Reason for recall

Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1148-2015
- **Recalling firm:** Actavis Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-06-04
- **Report date:** 2015-07-01
- **Termination date:** 2016-04-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2015

## Citation

> AI Analytics. FDA recall D-1148-2015. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1148-2015. Source: US FDA. Licensed CC0.

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