Recalls / Class II
Class IID-1085-2014
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.
- Affected lot / code info
- Lot #: 13J081, Exp 05/15
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.
Recalling firm
- Firm
- Actavis Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 99 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-12-09
- FDA classified
- 2014-02-11
- Posted by FDA
- 2014-02-19
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1085-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.