AVKARE Inc. FDA Recalls

2 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 4229Class IIIJul 20, 2022Labeling: Label Error on Declared Strength	Labeling: Label Error on Declared Strength	Class IIIDrugs	Jul 20, 2022
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-6Class IIIJun 9, 2021Failed Impurities Specification: Out of specification when m	Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.	Class IIIDrugs	Jun 9, 2021