May 15, 2024DrugsFDA
Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, ND
Hazard: Discoloration: Dotted and yellow spots on tablets
May 15, 2024DrugsFDA
Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, ND
Hazard: Discoloration: Dotted and yellow spots on tablets
May 15, 2024DrugsFDA
Acella Pharmaceuticals, LLC recalls Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, L
Hazard: Subpotent drug
May 15, 2024DrugsFDA
RemedyRepack Inc. recalls TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 7051
Hazard: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
May 15, 2024DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC
Hazard: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
May 15, 2024DrugsFDA
Rubicon Research Private Limited recalls traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plain
Hazard: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
May 15, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr.
Hazard: Sub-potent Drug; powder discoloration associated with decreased potency
May 15, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distri
Hazard: Sub-potent Drug; powder discoloration associated with decreased potency
May 15, 2024DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
May 15, 2024DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
May 15, 2024DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
May 8, 2024DrugsFDA
Viatris Inc recalls Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV
Hazard: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
May 8, 2024DrugsFDA
Hikma Injectables USA Inc recalls Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hik
Hazard: Labeling: Wrong Barcode
May 8, 2024DrugsFDA
Regeneron Pharmaceuticals Inc recalls EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactur
Hazard: Lack of Assurance of Sterility: Complaints of syringe breakage
May 8, 2024DrugsFDA
Imprimis NJOF, LLC recalls Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LL
Hazard: Out of specification for assay
May 8, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bri
Hazard: Failed Dissolution Specifications
May 8, 2024DrugsFDA
Imprimis NJOF, LLC recalls Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: I
Hazard: Subpotent Drug
May 1, 2024DrugsFDA
EPI Health, LLC recalls minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Labora
Hazard: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 1, 2024DrugsFDA
EPI Health, LLC recalls minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Labora
Hazard: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 1, 2024DrugsFDA
EPI Health, LLC recalls Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LL
Hazard: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 1, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man
Hazard: Failed Dissolution Specifications
May 1, 2024DrugsFDA
Cipla USA, Inc. recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton
Hazard: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
May 1, 2024DrugsFDA
FA Online Inc recalls ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Hazard: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
May 1, 2024DrugsFDA
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalls Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5
Hazard: Cross Contamination with Other Products
May 1, 2024DrugsFDA
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalls Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5
Hazard: Cross Contamination with Other Products
May 1, 2024DrugsFDA
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalls Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (
Hazard: Cross Contamination with Other Products
May 1, 2024DrugsFDA
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalls Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59
Hazard: Cross Contamination with Other Products
May 1, 2024DrugsFDA
Nomax Inc recalls FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., La
Hazard: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
May 1, 2024DrugsFDA
Nomax Inc recalls FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactu
Hazard: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
May 1, 2024DrugsFDA
Nomax Inc recalls GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax,
Hazard: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.