July 22, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;
Hazard: Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
July 22, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analge
Hazard: CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
July 22, 2020DrugsFDA
Keryx Biopharmaceuticals, Inc. recalls Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Bio
Hazard: cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
July 22, 2020DrugsFDA
Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:
Hazard: Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
July 22, 2020DrugsFDA
RemedyRepack Inc. recalls Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 1570
Hazard: FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
July 22, 2020DrugsFDA
Granules Pharmaceuticals Inc recalls Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (N
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmac
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmace
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmac
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmac
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 15, 2020DrugsFDA
Biogen MA Inc. recalls Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,
Hazard: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
July 15, 2020DrugsFDA
EMD Serono, Inc. recalls Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EM
Hazard: Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
July 15, 2020DrugsFDA
VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Us
Hazard: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
July 15, 2020DrugsFDA
VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 337
Hazard: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
July 15, 2020DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw
Hazard: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
July 15, 2020DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw
Hazard: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
July 15, 2020DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywo
Hazard: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
July 8, 2020DrugsFDA
Flexion Therapeutics, Inc. recalls Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits,
Hazard: Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
July 8, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc.,
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
July 8, 2020DrugsFDA
MasterPharm LLC recalls Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale,
Hazard: Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
July 8, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 0
Hazard: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
July 8, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant
Hazard: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
July 8, 2020DrugsFDA
The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufac
Hazard: CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
July 8, 2020DrugsFDA
Beaming White Llc recalls Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205
Hazard: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
July 8, 2020DrugsFDA
Beaming White Llc recalls Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 N
Hazard: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
July 8, 2020DrugsFDA
Beaming White Llc recalls Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White
Hazard: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal P
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
American Health Packaging recalls Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: Americ
Hazard: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
July 1, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton
Hazard: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
July 1, 2020DrugsFDA
Rising Pharmaceuticals, Inc. recalls Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pha
Hazard: Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.