FDA recall D-0223-2019

Product

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2018-09-28

Report date

2018-11-14

Termination date

2019-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nicholasville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2019