← FDA ENFORCEMENT
D-0029-2025Class II

BLI International, Inc.

Recalling firm
BLI International, Inc.
Product type
Drug
Status
Terminated
Report date
2024-11-06
Distribution
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Firm state
NY
Product quantity
4,901 cases/24 count each case
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Code / lot info

Lot # 24A27724, Exp 01/31/2027

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.