Recall Enforment Report D-1319-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mckesson Medical-Surgical Inc. Corporate Office, originally initiated on 06-29-2022 for the product 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. The product was recalled due to cgmp deviations: products were stored outside the drug label specifications.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1319-202206-29-202208-17-2022Class II67 bottlesMiralax (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-1315-202206-29-202208-17-2022Class II16 boxesEye-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-1316-202206-29-202208-17-2022Class II12 boxesSystane 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-1322-202206-29-202208-17-2022Class II1 JarA&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-1312-202206-29-202208-17-2022Class II45 boxesBisacodyl 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-1323-202206-29-202208-17-2022Class II113 bottlesDakin'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-1321-202206-29-202208-17-2022Class II1 boxPataday, 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-1325-202206-29-202208-17-2022Class II23 cartonsRacepinephrine 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-1318-202206-29-202208-17-2022Class II131 boxesDebrox, 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-1320-202206-29-202208-17-2022Class II40 boxesGenTeal 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-1311-202206-29-202208-17-2022Class II6 boxesTriple 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
D-1327-202206-29-202208-17-2022Class IIAlcohol 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-1326-202206-29-202208-17-2022Class II10 boxesSterile 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-1317-202206-29-202208-17-2022Class II9 boxesSystane 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-1314-202206-29-202208-17-2022Class II47 bottlesSystane, 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-1324-202206-29-202208-17-2022Class II1 boxAsthmanefrin 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-1313-202206-29-202208-17-2022Class II12 boxesNaphcon 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

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0065-0085Naphcon A Naphazoline Hydrochloride And Pheniramine MaleateSolution/ DropsOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0065-0429Systane Lubricant Polyethylene Glycol 400 And Propylene GlycolSolution/ DropsOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0065-0518Genteal Tears NIGHT-TIMEMineral Oil, White PetrolatumOintmentOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0065-0530Eye Stream Purified WaterSolutionOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0065-1433Opti-free Alcon Laboratories, Inc.
0065-1433Systane Balance Propylene GlycolEmulsionOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0065-4011Zaditor Ketotifen FumarateSolutionOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0065-8150Pataday Once Daily Relief Olopatadine HydrochlorideSolutionOphthalmicAlcon Laboratories, Inc.Human Otc Drug
0487-2784Asthmanefrin Racepinephrine HydrochlorideSolutionRespiratory (inhalation)Nephron Pharmaceuticals CorporationHuman Otc Drug
0487-5901S2 Racepinephrine HydrochlorideSolutionRespiratory (inhalation)Nephron Sc, Inc.Human Otc Drug
0498-42424242 First Aid Kit Honeywell Safety Products Usa, Inc
11523-0096A And D Original Lanolin And PetrolatumOintmentTopicalBayer Healthcare Llc.Human Otc Drug
11523-0096A And D Original Lanolin And PetrolatumOintmentTopicalBayer Healthcare Llc.Human Otc Drug
11523-4357Miralax Polyethylene Glycol 3350Powder, For SolutionOralBayer Healthcare Llc.Human Otc Drug
11523-7234Miralax Polyethylene Glycol 3350Powder, For SolutionOralBayer Healthcare Llc.Human Otc Drug
11523-7268Miralax Polyethylene Glycol 3350Powder, For SolutionOralBayer Healthcare Llc.Human Otc Drug
11523-7341Miralax Polyethylene Glycol 3350Powder, For SolutionOralBayer Healthcare Llc.Human Otc Drug
57896-443Bisacodyl BisacodylSuppositoryRectalGeri-care Pharmaceutical CorpHuman Otc Drug
63029-321Debrox Carbamide PeroxideLiquidAuricular (otic)Medtech Products Inc.Human Otc Drug
67777-121Alcohol Prep Isopropyl AlcoholSwabTopicalDynarex CorporationHuman Otc Drug
67777-300Alcohol AlcoholSwabTopicalDynarex CorporationHuman Otc Drug