Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations - presence of rubber particles found loose in the bulk 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Reason Failed Tablet/Capsule Specification : Capsule breakage
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations
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