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16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
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September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
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Page 637 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-559-2013 | Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | THE COMPOUNDING SHOP, INC. | Terminated | Class II | Jun 12, 2013 |
| D-563-2013 | Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | THE COMPOUNDING SHOP, INC. | Terminated | Class II | Jun 12, 2013 |
| D-565-2013 | Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | THE COMPOUNDING SHOP, INC. | Terminated | Class II | Jun 12, 2013 |
| D-544-2013 | Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-573-2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33. | Novartis Consumer Health | Terminated | Class III | Jun 12, 2013 |
| D-538-2013 | TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-526-2013 | BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-504-2013 | AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-542-2013 | Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-587-2013 | Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Pentec Health | Terminated | Class II | Jun 12, 2013 |
| D-524-2013 | BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-591-2013 | Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Pentec Health | Terminated | Class II | Jun 12, 2013 |
| D-533-2013 | CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-579-2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN | Petnet Solution Inc | Terminated | Class II | Jun 12, 2013 |
| D-594-2013 | Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Pentec Health | Terminated | Class II | Jun 12, 2013 |
| D-519-2013 | BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-586-2013 | Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Pentec Health | Terminated | Class II | Jun 12, 2013 |
| D-528-2013 | Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-518-2013 | Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-511-2013 | AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-522-2013 | Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-589-2013 | Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Pentec Health | Terminated | Class II | Jun 12, 2013 |
| D-510-2013 | AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16. | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-515-2013 | ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01 | TG United, Inc. | Terminated | Class II | Jun 12, 2013 |
| D-575-2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428. | Novartis Consumer Health | Terminated | Class III | Jun 12, 2013 |