D-1319-2022 | 06-29-2022 | 08-17-2022 | Class II | 67 bottles | Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1315-2022 | 06-29-2022 | 08-17-2022 | Class II | 16 boxes | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1316-2022 | 06-29-2022 | 08-17-2022 | Class II | 12 boxes | Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1322-2022 | 06-29-2022 | 08-17-2022 | Class II | 1 Jar | A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1312-2022 | 06-29-2022 | 08-17-2022 | Class II | 45 boxes | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1323-2022 | 06-29-2022 | 08-17-2022 | Class II | 113 bottles | Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1321-2022 | 06-29-2022 | 08-17-2022 | Class II | 1 box | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1325-2022 | 06-29-2022 | 08-17-2022 | Class II | 23 cartons | Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1318-2022 | 06-29-2022 | 08-17-2022 | Class II | 131 boxes | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1317-2022 | 06-29-2022 | 08-17-2022 | Class II | 9 boxes | Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1314-2022 | 06-29-2022 | 08-17-2022 | Class II | 47 bottles | Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1320-2022 | 06-29-2022 | 08-17-2022 | Class II | 40 boxes | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1324-2022 | 06-29-2022 | 08-17-2022 | Class II | 1 box | Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1313-2022 | 06-29-2022 | 08-17-2022 | Class II | 12 boxes | Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1327-2022 | 06-29-2022 | 08-17-2022 | Class II | | Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued) | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1326-2022 | 06-29-2022 | 08-17-2022 | Class II | 10 boxes | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
D-1311-2022 | 06-29-2022 | 08-17-2022 | Class II | 6 boxes | Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |