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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description 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.
Recall Number D-1085-2014
Classification Class II
Code Info Lot #: 13J081, Exp 05/15
Product Distributed Qty 99 cartons
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.

Event Detail

Event Id 67386
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Inc
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico