The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities. A carton labeled as 5 mg Lortab contained correctly labeled labeled unit dose 7.5 mg. Firm-initiated recall ongoing. Firm-initiated recall complete.
Firm estimates none remains on the market.
Firm-initiated field correction ongoing. Some units were packaged with a Beclovent actuator. Firm-initiated recall ongoing. Some tablets are debossed with an incorrect NDC number. Firm-initiated recall ongoing.