FDA (Drugs) recall action 89464
The FDA (Drugs) publishes a recall like this one as 56 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 56 pages.
cGMP deviations
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ultra Seal Corporation is voluntarily recalling MidNite Sleep Health melatonin tablets nationwide due to current good manufacturing practice (cGMP) deviations. Approximately 2.2 million bottles are affected.
Ultra Seal Corporation is recalling 1,486,050 packets of Nutralox Mint Antacid chewable tablets (calcium carbonate 420mg, 2-count packets) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Ultra Seal Corporation is recalling DBI 357 Super Magnum Quick Energy Stimulant caffeine tablets distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall includes 36-count, 100-count, and 500-count bottles, as well as 3-count packets.
Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.
Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.
Ultra Seal Corporation is recalling 448,300 packets of SINUS DECONGESTANT (phenylephrine HCl 5mg) tablets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects nationwide distribution.