Allegiant Health Recalls HealthA2Z Chewable Aspirin Due to Rubber Particles
Allegiant Health is recalling HealthA2Z Chewable Aspirin 81 mg because rubber particles were found in the bulk product.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a cGMP deviation (foreign material) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Allegiant Health is voluntarily recalling HealthA2Z Chewable Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets. The recall involves both packaged 36-count bottles and bulk product. The product is manufactured by Allegiant Health in Deer Park, NY.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations, specifically the presence of rubber particles found loose in the bulk product. The affected lot number is 6K28817, with expiration dates of 10/19 for the packaged bottles and 10/17 for the bulk product.
The recall covers 70,176 bottles and 9,000,000 tablets of bulk product distributed nationwide. Consumers should stop using the product and contact Allegiant Health for further instructions or a refund.
The recalled product
- Product
- HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
- Manufacturer
- Allegiant Health
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 (3)
- Lot # 6K28817
- Exp 10/19 (Packaged in bottle)
- 10/17 (Bulk)
Distribution
Distributed nationwide across the United States.
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