Drug Enforcement D-0029-2025

Superpotent Drug: Stability failure for assay at 6 months test time-point.

Status

Ongoing

Classification

Class II

Report Date

November 6, 2024

Termination Date

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Product Information

Product description
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Product quantity
4,901 cases/24 count each case
Reason for recall
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was shipped to two private label customers ( OH & MO) as a final packaged product.

Location & Firm

Recalling firm
BLI International, Inc.
Address
75 N Industry Ct, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0029-2025
Event ID
95590
Recall initiation date
October 21, 2024
Center classification date
October 30, 2024
Code info
Lot # 24A27724, Exp 01/31/2027
More code info
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