Recalls / Class II
Class IID-1442-2020
Product
Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
- Affected lot / code info
- 01-21-2020:42@8, BUD 7/19/2020 01-24-2020:59@1, BUD 7/22/2020 02-04-2020:65@11, BUD 8/2/2020
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
- 134 troches
- 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-1442-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.