Status
Terminated
Drug Enforcement D-0871-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Classification
Class III
Report Date
June 21, 2023
Termination Date
May 29, 2024
Product Information
- Product description
- Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
- Product quantity
- 48,989 bottles
- 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
- Amring Pharmaceuticals Inc
- Address
-
1205 Westlakes Dr Ste 275, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0871-2023
- Event ID
- 92458
- Recall initiation date
- June 12, 2023
- Center classification date
- June 14, 2023
- Code info
- Lots: X220317A and X220318A, exp. date 09/25
- More code info
- —