D-1085-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2014
- Initiation Date
- December 9, 2013
- Termination Date
- August 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 cartons
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 13J081, Exp 05/15