August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-009
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief,
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-0
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) b
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) b
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long La
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops,
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-4
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibio
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heig
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heig
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 0772
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
August 17, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceu
Hazard: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
August 17, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuti
Hazard: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
August 10, 2022DrugsFDA
Ultra Supplement LLC recalls SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor
Hazard: Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
August 10, 2022DrugsFDA
Distributor RFR, LLC. recalls SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
August 10, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35,
Hazard: Defective Container: Tube split from side seam
August 10, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavi
Hazard: Failed Dissolution Specifications: below specification limits for dissolution.
August 10, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis
Hazard: Failed Dissolution Specifications: below specification limits for dissolution.
August 10, 2022DrugsFDA
Tolmar, Inc. recalls Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tu
Hazard: Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
August 3, 2022DrugsFDA
Pfizer Inc. recalls Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) furthe
Hazard: Presence of particulate matter: particulate identified as a beetle.
August 3, 2022DrugsFDA
Eco Lips, Inc recalls Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4
Hazard: Failed Dissolution Specifications
August 3, 2022DrugsFDA
Eco Lips, Inc recalls Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) pe
Hazard: Failed Dissolution Specifications
August 3, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Indi
Hazard: Failed Dissolution Specifications
August 3, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Ind
Hazard: Failed dissolution specifications.