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 voluntarily recalled PAINAID PMF Premenstrual Formula packets nationwide due to cGMP (current Good Manufacturing Practice) deviations.
Ultra Seal Corporation is recalling approximately 2.3 million packets of PAINAID pain relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations in manufacturing processes.
Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant packets due to current Good Manufacturing Practice (cGMP) deviations. The voluntary nationwide recall affects 447,050 packets.
Ultra Seal Corporation is recalling CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets in 2-count packets nationwide due to current good manufacturing practice (cGMP) deviations.
Ultra Seal Corporation is recalling MIRALAC calcium carbonate 420mg tablets in mint flavor due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 409,890 packets distributed nationwide.
Ultra Seal Corporation is recalling 1,309,800 packets of Mint Flavored Antacid (Calcium Carbonate 420mg) distributed nationwide due to cGMP deviations. The recall is voluntary and applies to specific lot numbers with expiration dates in 2022.
Ultra Seal Corporation is voluntarily recalling CYSTEX Urinary Pain Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects specific lot numbers distributed in 40-count and 20-count blister packages.
Ultra Seal Corporation is recalling Sinus Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. Affected lots are AK9651 (exp. 06/2022) and AK9437 (exp. 01/2022).
Ultra Seal Corporation is recalling MAGNACAL calcium carbonate 420 mg tablets (Lot #AK9768, expiration 08/2022) nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated on January 24, 2022.
Ultra Seal Corporation is recalling 227,010 packets of Cold Relief Severe Pain/Cough due to cGMP deviations. The recall affects Lot #AK9436 (expiration 01/2022) distributed nationwide.
Ultra Seal Corporation is recalling AYPANAL Non-aspirin Pain Reliever tablets (acetaminophen 325 mg) in 2-count packets nationwide due to Current Good Manufacturing Practice (cGMP) deviations.
Ultra Seal Corporation is recalling approximately 1.18 million packets of Regular Strength Pain Reliever nationwide due to current good manufacturing practice (cGMP) deviations.
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5 mg caplets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects approximately 40,344 blisters of the product.
Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold coated tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects Lot #AK9841 with expiration date 10/2022.
Ultra Seal Corporation is recalling approximately 1.47 million packets of Electrolyte Supplement Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.
Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.
Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.
CVS Health Natural Sleep Aid Chewable Tablets (melatonin 1.5mg) in cherry flavor are being recalled nationwide due to cGMP manufacturing deviations. The manufacturer, Ultra Seal Corporation, initiated the voluntary recall of 241,560 bottles.
Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant packets containing phenylephrine HCl 5mg due to current good manufacturing practice (cGMP) deviations. The recall affects 3,508,200 packets distributed nationwide.
Ultra Seal Corporation is recalling DILOTAB II Sinus and Cold Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. Approximately 2.7 million packets containing acetaminophen 325 mg and phenylephrine HCl 5 mg are affected.
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets due to cGMP (current good manufacturing practice) deviations. The recall affects 113,040 packets and 7,132 bottles distributed nationwide.
Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.
Ultra Seal Corporation is recalling FEM-PRIN Menstrual Relief tablets (223,090 packets) distributed nationwide due to cGMP deviations. The recall was voluntary and initiated on January 24, 2022.
Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 packets distributed nationwide.