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More DESI Tannates removed from market

FDA continues to remove unapproved DESI products from the market.  Generally, it appears that the removals occur when the manufacturing site is inspected and the FDA identifies unapproved products being made.  The latest manufacturer to be hit is ANIP Acquisition Company.  During an inspection of the firms facilities in Gulfport, MS this past February, the FDA inspector found cGMP issues with laboratory testing, the main objections being inadequate dissolution test methods and API identification.  The firm didn’t take adequate remedial action and the FDA issued a Warning Letter.  The offending products are tannates of various cough/cold medications listed below.  The firm offered to remove some but not all of these products (no rationale is given in the Warning Letter) and the FDA replied that all must be removed.

– Aldex CT chewable tablets (Diphenhydramine HC112.5 mg, Phenylephrine HCI 5 mg)
– (b)(4) tannate for oral suspension (Pyrilamine Maleate 16 mg, Phenylephrine HCl 5 mg)
– (b)(4) tannate for oral suspension (Pyrilamine Maleate 16 mg, Phenylephrine HCI 5 mg, Dextromethorphan HBr 15 mg)
– (b)(4) suspension (Dextromethorphan HBr 15 mg, Pseudoephedrine HCl 30 mg, Guaifenesin 175 mg)
– (b)(4) tannate suspension (Carbetapentane Citrate 20 mg, Pseudoephedrine HCl 30 mg)
– (b)(4) tannate suspension (Carbetapentane Citrate 7.5 mg, Guaifenesin 200mg)
– (b)(4) tannate suspension (Carbetapentane Citrate 7.5 mg, Pseudoephedrine HCI 30 mg)
– Brompheniramine Phenylephrine Tannate Suspension (Phenylephrine Tannate 20 mg, Brompheniramine Tannate 12 mg)
– (b)(4) chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg)
– (b)(4) chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg, Dextromethorphan HBr 15 mg)
– Duratuss AC 12 tannate suspension (Dextromethorphan HBr 15 mg, Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 15 mg)
– Duratuss DM 12 tannate suspension (Dextromethorphan Hydrobromide 15 mg, Guaifenesin 225 mg)
– Guaifenesin and Phenylephrine Hydrochloride syrup (each 5 ml contains: Guaifenesin 200 mg, Phenylephrine Hydrochloride 5 mg)
– (b)(4) tablets (Phenylephrine Tannate 25 mg, Chlorpheniramine Tannate 9 mg)
– Respi-TANN tannate suspension and (b)(4) (each 5 ml contains: Carbetapentane Citrate 20 mg, Pseudoephedrine HCI 30 mg)
– (b)(4) (Carbetapentane Citrate 20 mg, Pseudoephedrine HC130 mg)
– Respi-TANN PD tannate suspension and (b)(4) (each 5 ml contains: Carbetapentane Citrate 7.5 mg, Pseudoephedrine HC130 mg)
– (b)(4) tannate suspension grape flavor (each 5 ml contains: Carbetapentane Citrate 7.5 mg, Guaifenesin 200 mg)
– TanaCof XR Antihistamine (each 5ml contains: Brompheniramine Tannate 8 mg)
– TanaHist-D Pediatric Suspension Drops (Chlorpheniramine Tannate 2 mg Phenylephrine Tannate 6 mg)
– TanaHist-PD Pediatric Suspension Drops (each ml contains: Chlorpheniramine Tannate 2 mg)
– (b)(4) tannate suspension (Guaifenesin 200 mg, Phenylephrine HCI 20 mg, Dextromethorphan HBr 40 mg)
– (b)(4) tannate suspension Extended Release Dosing Grape Flavor (Guaifenesin 200 mg, Phenylephrine HCI 20 mg, Dextromethorphan HBr 40 mg)
– (b)(4) (Guaifenesin 150 mg, Carbetapentane Citrate 7.5 mg)
– (b)(4) Grape Flavor (Guaifenesin 150 mg, Carbetapentane Citrate 7.5 mg)
– (b)(4) tannate suspension (Brompheniramine Maleate 6 mg, Phenylephrine HCI 10 mg)
– (b)(4)Chewable Tablets (Brompheniramine Maleate 6 mg, Phenylephrine HCI 15 mg)
– (b)(4) tannate suspension (Brompheniramine Maleate 6 mg, Phenylephrine HCI 10 mg, Carbetapetane Citrate 25 mg)
– (b)(4) Cherry Bubblegum flavored tannate suspension (each 5 ml contains: Pseudoephedrine HCI 15 mg, Pyrilamine Maleate 15 mg)
– (b)(4) Grape Flavored tannate suspension (each 5 ml contains: Dextromethorphan HBr 15 mg, Pseudoephedrine HCI 15 mg, Pyrilamine Maleate 15 mg)