PlainRecalls
FDA Drug Moderate Class II Terminated

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

Reported: November 6, 2024 Initiated: October 21, 2024 #D-0029-2025

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.

Details

Recalling Firm
BLI International, Inc.
Units Affected
4,901 cases/24 count each case
Distribution
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Location
Deer Park, NY

Frequently Asked Questions

What product was recalled?
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24. Recalled by BLI International, Inc.. Units affected: 4,901 cases/24 count each case.
Why was this product recalled?
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 6, 2024. Severity: Moderate. Recall number: D-0029-2025.