D-0029-2025 Class II Terminated
FDA drug recall D-0029-2025 was initiated by BLI International, Inc. on October 21, 2024 and is designated Class II. Reason for recall: Superpotent Drug: Stability failure for assay at 6 months test time-point. The recall status is terminated (terminated December 5, 2025). Affected quantity: 4,901 cases/24 count each case.
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2024
- Initiation Date
- October 21, 2024
- Termination Date
- December 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,901 cases/24 count each case
Product Description
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Reason for Recall
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Distribution Pattern
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Code Information
Lot # 24A27724, Exp 01/31/2027