Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specification; at the 12 month time interval.
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
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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