Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2025-02-19
Distribution
Nationwide in the USA
Firm state
TN
Product quantity
341 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Out of Specification for Dissolution
Product description
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Code / lot info
Lot 45279, Exp 03/31/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.