Class II
Terminated
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.
- Company
- Actavis Inc
- Recall Initiated
- December 9, 2013
- Posted
- February 19, 2014
- Recall Number
- D-1085-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 99 cartons
- Firm Location
- Parsippany, NJ, United States
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
Lot / Code Info
Lot #: 13J081, Exp 05/15
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