FDA Drug Recalls

Recalls / Class III

Class IIID-1483-2014

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

Affected lot / code info
Lot 0093943

Why it was recalled

Failed Dissolution Specification; at the 12 month time interval.

Recalling firm

Firm
Mckesson Packaging Services
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7101 Weddington Rd NW, Concord, North Carolina 28027-3412

Distribution

Quantity
1,511,250 tablets
Distribution pattern
Nationwide

Timeline

Recall initiated
2014-06-19
FDA classified
2014-07-28
Posted by FDA
2014-08-06
Terminated
2017-04-27
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1483-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls