FDA Drug Recalls

Recalls / Class III

Class IIID-0834-2016

Product

SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.

Affected lot / code info
Lot 0110701

Why it was recalled

Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.

Recalling firm

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

Distribution

Quantity
1,676 boxes
Distribution pattern
Nationwide

Timeline

Recall initiated
2016-04-12
FDA classified
2016-04-28
Posted by FDA
2016-05-04
Terminated
2017-03-17
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0834-2016. 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