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Recall Observatory FDA recall evidence

Drug product

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

D-0223-2019

September 28, 2018

Class II

Product summary

Firm
Tailor Made Compounding
Event
Event 81337
Status
Terminated
Classification
Class II
Quantity
10,280 Vials
Official record key
drug-enforcement:D-0223-2019

Official wording

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

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

Distribution pattern: Nationwide USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing