REGULATORY INTELLIGENCE·Recall
AvKARE Initiates Nationwide Class II Recall of Norgestimate and Ethinyl Estradiol Tablets Over Content Uniformity Failure
AvKARE has initiated a nationwide Class II recall of 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets due to failed content uniformity specifications. This event, originating from their Pulaski, TN facility, highlights critical quality control vulnerabilities. Procurement and regulatory teams must assess immediate supply chain risks and AvKARE's extensive history of compliance issues.
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