FDA Recall
Terminated
Historical recordClass II
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
by Strides Pharma Inc.
- Reason
- Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
by AVKARE Inc.
- Reason
- Labeling: Label Error on Declared Strength
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
by CIPLA
- Reason
- Lack of Assurance of Sterility: Complaints received of defective container closure.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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)
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- CGMP Deviations: products were stored outside the drug label specifications.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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