Drug recalls

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

AvKARE · Out of Specification for Dissolution

Class IIOngoingD-0224-2025
Status
Ongoing
City
Pulaski
State
TN
Country
United States
Classification
Class II
Product type
Drugs
Event ID
96172
Recalling firm
AvKARE
Address 1
615 N 1st St
Postal code
38478-2403
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA
Recall number
D-0224-2025
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
Product quantity
341 cartons
Reason for recall
Out of Specification for Dissolution
Recall initiation date
20250121
Center classification date
20250211
Report date
20250219
Code info
Lot 45279, Exp 03/31/2025
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.