Drug Enforcement D-0875-2023

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Status

Ongoing

Classification

Class III

Report Date

June 21, 2023

Termination Date

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Product Information

Product description
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Product quantity
592 cartons
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
AVKARE LLC
Address
615 N 1st St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0875-2023
Event ID
92535
Recall initiation date
June 13, 2023
Center classification date
June 15, 2023
Code info
Lot: 44286 Exp. 02/2025
More code info
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