Why it was recalled
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Product description
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Lot numbers, UPCs & expiration codes
Lot # 24A27724, Exp 01/31/2027
Where it was sold
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0029-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 21, 2024
- FDA report date
- Nov 6, 2024
- Quantity
- 4,901 cases/24 count each case
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BLI International, Inc.
Original FDA data
Every field from FDA enforcement report D-0029-2025, exactly as published.
Show all FDA fields
- City
- Deer Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 95590
- Address
- 75 N Industry Ct
- Code information
- Lot # 24A27724, Exp 01/31/2027
- Postal code
- 11729-4601
- Report date
- Nov 6, 2024
- Product type
- Drugs
- Recall number
- D-0029-2025
- Classification
- Class II
- Recalling firm
- BLI International, Inc.
- Product quantity
- 4,901 cases/24 count each case
- Termination date
- Dec 5, 2025
- Reason for recall
- Superpotent Drug: Stability failure for assay at 6 months test time-point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
- Distribution pattern
- Product was shipped to two private label customers ( OH & MO) as a final packaged product.
- Recall initiation date
- Oct 21, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 30, 2024