Why it was 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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 13J081, Exp 05/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1085-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 9, 2013
- FDA report date
- Feb 19, 2014
- Quantity
- 99 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-1085-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67386
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 13J081, Exp 05/15
- Postal code
- 07054-1120
- Report date
- Feb 19, 2014
- Product type
- Drugs
- Recall number
- D-1085-2014
- Classification
- Class II
- Recalling firm
- Actavis Inc
- Product quantity
- 99 cartons
- Termination date
- Aug 4, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 9, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2014