Trelstar — Class II drug recall D-1085-2014
Terminated recall by Actavis Inc, reported 2014-02-19, distributed nationwide. Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3
| Recall number | D-1085-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2013-12-09 |
| Classified | 2014-02-11 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 99 cartons |
| Reason classes | labeling, potency |
| NDC | 52544-0154-02, 52544-0188-76 |
| Lot numbers | 05/15, 13J081 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1085-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.