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Recall Observatory FDA recall evidence

Drug product

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

D-1483-2014

June 19, 2014

Class III

Product summary

Firm
Mckesson Packaging Services
Event
Event 68652
Status
Terminated
Classification
Class III
Quantity
1,511,250 tablets
Official record key
drug-enforcement:D-1483-2014

Official wording

Reason: Failed Dissolution Specification; at the 12 month time interval.

Code information: Lot 0093943

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specification