FDA Drug Recalls

Recalls / Class II

Class IID-1437-2020

Product

Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

Affected lot / code info
01-23-2020:33@15, BUD 7/21/2020 02-07-2020:48@3, BUD 8/5/2020 02-26-2020:09@15, BUD 8/24/2020

Why it was recalled

Lack of Processing Controls (lack of assurance of conformity to specifications).

Recalling firm

Firm
MasterPharm LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
11502 Liberty Ave Fl 2, N/A, South Richmond Hill, New York 11419-1902

Distribution

Quantity
900 capsules
Distribution pattern
Nationwide in the U.S.

Timeline

Recall initiated
2020-07-02
FDA classified
2020-07-29
Posted by FDA
2020-08-05
Terminated
2024-02-23
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1437-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.