FDAClass IIFebruary 19, 2014

Trelstar recall: Labeling Error

Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL…

Why was Trelstar 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 13J081, Exp 05/15

Product
Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL…
Recalling firm
Actavis Inc
Quantity
99 cartons
Distribution
Nationwide and Puerto Rico
Recall date
February 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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