Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT SKU 913724 BAYER BACK BODY EX STRGTH CAPLETS 24CT SKU 900438 BAYER LOW DOSE 81 MG TABLET 120 CT SKU 916070 BAYER ASPIRIN 325MG TABLET 24CT SKU 913996 BAYER LOW DOSE TABLET 32CT SKU 915641 BAYER 81MG CHEWABLE TABLET 36 CT SKU 916078 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
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
Reason CGMP Deviations
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