FDA recall D-0029-2025

BLI International, Inc. · Class II · drug

Product

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

Product was shipped to two private label customers ( OH & MO) as a final packaged product.

Key facts

Status
Terminated
Initiation date
2024-10-21
Report date
2024-11-06
Termination date
2025-12-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deer Park, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0029-2025