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 BroveX PSB Liquid antihistamine and decongestant products because they are underdosed or have 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 348 bottles of AMBI 25CPD/200GFN antitussive and expectorant due to CGMP deviations involving incorrect dosage.
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 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
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 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 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 Lusair Liquid, an over-the-counter product, because it may be 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 12,198 bottles of Tri-Dex PE because the product is underdosed or has 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 TL Hist DM 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 due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling ED A-Hist Tablets 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 Z-Dex Pediatric Drops because the products are underdosed or have an incorrect dosage regime.
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-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.