FDA classifies Apothecary Pharma compounded tirzepatide recall as Class II
The pharmacy pulled specified lots of 18 mg/mL, 4 mL sterile multidose vials in September over sterility assurance concerns; FDA classified the action in October.
MH
By Maren Holt · Senior Reporter, GLP-1
Oct 20 14:00 ETSource: Hudson Valley Post
The wire
- 01Apothecary Pharma LLC voluntarily recalled specific lots of compounded tirzepatide injection, 18 mg/mL in 4 mL multidose vials, because sterility could not be assured; FDA classified it Class II in October.
- 02Class II means exposure could cause temporary or medically reversible harm, with serious harm considered remote; only the named compounded lots are affected, not brand Mounjaro or Zepbound.
- 03Patients should check vial lot numbers and contact prescribers; the recall does not establish that any individual vial is contaminated, and the pharmacy initiated it in September.
From the source
Read at hudsonvalleypost.comCompounded Tirzepatide Recall Covers 22 Lots Through November 2026
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