D-0223-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 14, 2018
- Initiation Date
- September 28, 2018
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,280 Vials
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
Distribution Pattern
Nationwide USA
Code Information
Lot, exp: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805, exp 7/19; 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801, exp 8/19