Drug 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.
D-1085-2014
Product summary
- Firm
- Actavis Inc
- Event
- Event 67386
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 cartons
- Official record key
drug-enforcement:D-1085-2014
Official wording
Reason: 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.
Code information: Lot #: 13J081, Exp 05/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Error