Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus...
FDA Recall #D-1085-2014 — Class II — December 9, 2013
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.
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.
Recalling Firm
Actavis Inc — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
99 cartons
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 13J081, Exp 05/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated