Actavis Recalls Trelstar Injectable Suspension Due to Labeling Error
Actavis is recalling 99 cartons of Trelstar 11.25 mg due to a labeling error where the vial was marked 3.75 mg. The product was distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding the declared strength, which fits the criteria for moderate severity involving low-risk contamination or labeling issues without reported injuries.
Plain-English summary
Actavis Inc is voluntarily recalling 99 cartons of Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial, 11.25 mg, Rx Only. The recall is due to a labeling error where the carton and kit were labeled as 11.25 mg, but the vial inside was labeled as 3.75 mg instead of 11.25 mg.
The affected product is identified by Lot # 13J081 with an expiration date of 05/15. The product was distributed nationwide and in Puerto Rico. The recall is classified as FDA Class II.
Healthcare providers and patients should discontinue use of the affected product and contact their pharmacist or healthcare provider for further instructions. The product is distributed by Watson Pharma, Inc., and manufactured by Debio RP, Switzerland.
The recalled product
- 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…
- Manufacturer
- Actavis Inc
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 99
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 13J081
- Exp 05/15
Distribution
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