FDA Drug Recalls

Recalls / Class III

Class IIID-0338-2018

Product

Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

Affected lot / code info
Lot #: 0114588, Exp 10/18

Why it was recalled

Subpotent Drug: Out of specification for assay (stability testing)

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
24120 cups
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2018-01-29
FDA classified
2018-02-08
Posted by FDA
2018-02-14
Terminated
2020-11-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0338-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.