PlainRecalls
FDA Drug Moderate Class II Terminated

Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

Reported: November 14, 2018 Initiated: September 28, 2018 #D-0223-2019

Product Description

Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date

Details

Recalling Firm
Tailor Made Compounding
Units Affected
10,280 Vials
Distribution
Nationwide USA
Location
Nicholasville, KY

Frequently Asked Questions

What product was recalled?
Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356. Recalled by Tailor Made Compounding. Units affected: 10,280 Vials.
Why was this product recalled?
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Which agency issued this recall?
This recall was issued by the FDA Drug on November 14, 2018. Severity: Moderate. Recall number: D-0223-2019.