# FDA recall D-1085-2014

> **Actavis Inc** · Class II · drug recall initiated 2013-12-09.

## Product

Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland.

## Reason for recall

Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1085-2014
- **Recalling firm:** Actavis Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-09
- **Report date:** 2014-02-19
- **Termination date:** 2014-08-04

- **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-1085-2014

## Citation

> AI Analytics. FDA recall D-1085-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1085-2014. Source: US FDA. Licensed CC0.

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