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Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, ...

FDA Recall #D-0029-2025 — Class II — October 21, 2024

Recall #D-0029-2025 Date: October 21, 2024 Classification: Class II Status: Terminated

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.

Recalling Firm

BLI International, Inc. — Deer Park, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

4,901 cases/24 count each case

Distribution

Product was shipped to two private label customers ( OH & MO) as a final packaged product.

Code Information

Lot # 24A27724, Exp 01/31/2027

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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