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 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling ED A-Hist Tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling NoHist Tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling 12,198 bottles of Tri-Dex PE because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling 2,532 bottles of TL-DEX DM cough suppressant because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling BroveX PSB DM Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 348 bottles of AMBI cough syrup because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling Poly-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Dallergy tablets because they are underdosed or have an incorrect dosage regime. The recall affects specific lots distributed in five states.
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling 348 bottles of AMBI 25CPD/200GFN antitussive and expectorant due to CGMP deviations involving incorrect dosage.
TG United, Inc. is recalling ZoDen DM Drops because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling Poly Hist Forte nasal decongestant tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Mesehist WC cough and cold medicine due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
TG United, Inc. is recalling 886 bottles of AMBI 40PSE/400GFN tablets because the products are underdosed or have an incorrect dosage regime.