Actavis Inc recalls Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose De
Recalled February 19, 2014 · FDA recall D-1085-2014 · Actavis
Hazard
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. · FDA Class II
Units
99 cartons
Sold at
Nationwide and Puerto Rico
Description
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.
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.
Manufacturer(s)
Actavis Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →