Recalls / Class II
Class IID-0029-2025
Product
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
- Brand name
- Chlorpheniramine Maleate 4mg
- Generic name
- Chlorpheniramine Maleate 4mg
- Active ingredient
- Chlorpheniramine Maleate
- Route
- Oral
- NDC
- 53185-277
- FDA application
- M012
- Affected lot / code info
- Lot # 24A27724, Exp 01/31/2027
Why it was recalled
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Recalling firm
- Firm
- BLI International, Inc.
- Manufacturer
- Athlete's Needs, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 75 N Industry Ct, N/A, Deer Park, New York 11729-4601
Distribution
- Quantity
- 4,901 cases/24 count each case
- Distribution pattern
- Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Timeline
- Recall initiated
- 2024-10-21
- FDA classified
- 2024-10-30
- Posted by FDA
- 2024-11-06
- Terminated
- 2025-12-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0029-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.