D-1085-2014 Class II Terminated
FDA drug recall D-1085-2014 was initiated by Actavis Inc on Dec 9, 2013 and is designated Class II. 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. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 99 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 19, 2014
- Initiation Date
- Dec 9, 2013
- Termination Date
- Aug 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1085-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026