FDA Drug Recalls

Recalls / Class II

Class IID-0421-2019

Product

Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00

Affected lot / code info
N/A

Why it was recalled

Lack of Processing Controls.

Recalling firm

Firm
Duren Health Mart Pharmacy
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
215 Dexter L Woods Memorial Blvd, N/A, Waynesboro, Tennessee 38485-2416

Distribution

Quantity
840 capsules
Distribution pattern
TN only

Timeline

Recall initiated
2018-12-17
FDA classified
2019-01-28
Posted by FDA
2019-02-06
Terminated
2022-01-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0421-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls