FDA Recall D-0875-2023
AVKARE LLC · Pulaski, TN
Class III Ongoing 1066 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall record
- Recall number
D-0875-2023- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2023-06-13
- Classified by FDA Center
- 2023-06-15
- FDA published
- 2023-06-21
- Recalling firm
- AVKARE LLC
- Firm location
- Pulaski, TN
Drug identification
- Brand name(s)
- TRANEXAMIC ACID
- Generic name(s)
- TRANEXAMIC ACID
- Manufacturer(s)
- AvPAK
- NDC(s)
50268-772- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.