FDA Drug Recalls

Recalls / Class II

Class IID-1172-2018

Product

Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 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 #: 0116158 Exp. 4/30/19; 0113903, 0113902, 0113901, Exp. 8/31/18

Why it was recalled

Supterpotent Drug

Recalling firm

Firm
Mckesson Corporation
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
4836 Southridge Blvd, N/A, Memphis, Tennessee 38141-8300

Distribution

Quantity
1531 cartons
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2018-08-14
FDA classified
2018-09-05
Posted by FDA
2018-09-12
Terminated
2020-11-25
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1172-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.