FDA (Drugs) recall action 64188
The FDA (Drugs) publishes a recall like this one as 44 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 44 pages.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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.
TG United, Inc. is recalling CPM / PSE Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling TL Hist DM antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 1,398 bottles of AMBI cough syrup in five states because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling 13,031 bottles of TL-Hist PD Drops because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling 348 bottles of AMBI cough suppressant and expectorant due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling Lusair Liquid, an over-the-counter product, because it may be underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Dallergy Chewable Tablets because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 352 bottles of AMBI 25DPH/7.5PEH Antihistamine, Nasal Decongestant due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling BroveX PSB Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Cardec Drops nasal decongestant because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling BroveX PSE antihistamine and nasal decongestant tablets because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Mesehist DM cough and cold medicine because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling Z-Dex Pediatric Drops because the products are underdosed or have an incorrect dosage regime.