FDA (Drugs) recall action 89334
The FDA (Drugs) publishes a recall like this one as 33 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 33 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.
ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.
ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
ULTRAtab Laboratories is recalling approximately 6.2 million acetaminophen 500 mg tablets due to current good manufacturing practice (CGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
ULTRAtab Laboratories is recalling Legatrin bulk tablets due to manufacturing deviations that may affect product quality and safety. The company voluntarily initiated the recall after distributing approximately 14 million tablets to three distributors.
ULTRAtab Laboratories is recalling 4-Component Cold Tabs in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed to three distributors.
ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.