AvKARE, Inc.
Overview
AvKARE, Inc. is a leading provider in the pharmaceutical distribution sector, specializing in servicing the healthcare needs for hospitals, healthcare facilities, and the government. As a private company, AvKARE has established a reputation for quality and reliability in the distribution of pharmaceuticals.
Therapeutic areas
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2026-03-04
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- recall — Class II2026-01-14
Out of specification for dissolution.
- recall — Class II2025-10-15
Failed Content Uniformity Specifications
- recall — Class II2025-09-17
Presence of a foreign substance.
- recall — Class II2025-09-17
Presence of a foreign substance.
- recall — Class III2025-07-09
Failed Impurity/Degradation Specifications
- recall — Class III2025-07-09
Failed Impurity/Degradation Specifications
- recall — Class II2025-06-18
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- recall — Class II2025-06-18
Failed Dissolution Specifications
- recall — Class II2025-02-26
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
- recall — Class II2025-02-19
Out of Specification for Dissolution
- recall — Class II2025-01-08
Failed Dissolution Specifications
- recall — Class III2025-01-08
LABELING: LABEL MIX-UP
- recall — Class III2025-01-08
LABELING: LABEL MIX-UP
- recall — Class II2024-12-11
Labeling: Label Mix-Up
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