CLASS II Drug recall · Reported 19 Feb 2014 · FDA Enforcement Report
Trelstar (triptorelin pamoate) recalled by Actavis
Actavis is recalling Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (, distributed nationwide in the US. The recall was initiated on 9 Dec 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1085-2014
- FDA event ID
- 67386
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2013
- FDA classified
- 11 Feb 2014
- Reported
- 19 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Dec 2013 | Recall initiated by company | |
| 11 Feb 2014 | Classified by FDA | +64 days |
| 19 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 13J081, Exp 05/15
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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