February 1, 2023DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specification
February 1, 2023DrugsFDA
Accord Healthcare, Inc. recalls Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703,
Hazard: Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
January 25, 2023DrugsFDA
Intersect ENT, Inc. recalls SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menl
Hazard: Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
January 25, 2023DrugsFDA
Southwest Iowa Renewable Energy LLC recalls SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, a
Hazard: CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
January 25, 2023DrugsFDA
Amerisource Health Services LLC recalls Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Co
Hazard: Failed Impurities/Degradations Specifications
January 25, 2023DrugsFDA
Fisher Scientific Co., LLC recalls Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific:
Hazard: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
January 25, 2023DrugsFDA
Fisher Scientific Co., LLC recalls Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per cas
Hazard: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
January 25, 2023DrugsFDA
MACLEODS PHARMA USA, INC recalls Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0
Hazard: Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
January 25, 2023DrugsFDA
Lannett Company Inc. recalls Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distribu
Hazard: Failed Impurity/Degradation Specifications
January 25, 2023DrugsFDA
Lannett Company Inc. recalls Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: La
Hazard: Failed Impurity/Degradation Specifications
January 25, 2023DrugsFDA
Ascend Laboratories, LLC recalls Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratori
Hazard: Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
January 25, 2023DrugsFDA
Akorn, Inc. recalls Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6004
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL droppe
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake For
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Oper
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only,
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufac
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, I
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufac
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Fo
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045;
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manu
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 6
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL droppe
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinos
Hazard: CGMP Deviations: