FDA classifies Apothecary Pharma compounded tirzepatide recall as Class II
The North Carolina pharmacy recalled 22 vials over lack of sterility assurance, months after an FDA warning letter citing serious sterile-production deficiencies.
MH
By Maren Holt · Senior Reporter, GLP-1
Oct 20 20:53 ETSource: Los Angeles Times
The wire
- 01Apothecary Pharma voluntarily recalled 22 vials of compounded tirzepatide injection last month for lack of assurance of sterility; FDA upgraded the classification to Class II this month.
- 02The pharmacy received a December warning letter after inspections in September 2024 and January and May 2025 found serious deficiencies in sterile drug production and labeling at its North Carolina outsourcing facility.
- 03Class II means exposure may cause temporary or medically reversible harm with low probability of serious effects; FDA has not confirmed the products were contaminated.
From the source
Read at latimes.comSome GLP-1 injections recalled due to ‘lack of assurance of sterility’
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