OTC Antihistamine Recalled for Stability Failure and Superpotent Concentration
BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a stability failure resulting in superpotent drug product with no reported illnesses or injuries. The hazard qualifies as risk-of-harm where injury has not yet been reported, due to higher-than-labeled active ingredient concentration.
Plain-English summary
Chlorpheniramine Maleate 4 mg tablets manufactured by BLI International, Inc. for Athlete's Needs are being recalled due to a stability failure. Testing revealed that the product is superpotent, meaning the active ingredient concentration exceeds the specified limits at the 6-month stability test interval.
The recall affects 4,901 cases of product (24 tablets per case) identified as Lot #24A27724, expiring 01/31/2027. The finished product was distributed to two private label customers in Ohio and Missouri.
Consumers should stop using the product and contact a healthcare provider if they have questions about alternative antihistamine treatments. Customers with affected inventory should contact the manufacturer for return or replacement instructions.
The recalled product
- Product
- CHLORPHENIRAMINE MALEATE 4MG (CHLORPHENIRAMINE MALEATE 4MG)
- Brand
- CHLORPHENIRAMINE MALEATE 4MG
- Manufacturer
- BLI International, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 24A27724
- Exp 01/31/2027
UPCs (1)
- 0092617099706
Distribution
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