January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged i
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multipl
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged i
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Direct Rx recalls Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, D
Hazard: cGMP deviation: discontinue of stability support for product.
January 18, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 212
Hazard: Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
January 18, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
RemedyRepack Inc. recalls Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-06
Hazard: Failed Impurities/Degradation specifications
January 11, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded
Hazard: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
January 11, 2023DrugsFDA
Pfizer Inc. recalls Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case
Hazard: Lack of assurance of sterility: Bags have the potential to leak.
January 11, 2023DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Mary
Hazard: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
January 11, 2023DrugsFDA
Eugia US LLC recalls Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics P
Hazard: Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
January 4, 2023DrugsFDA
Apotex Corp. recalls Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg
Hazard: Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
January 4, 2023DrugsFDA
NCH Life Sciences LLC recalls Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464
Hazard: CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
January 4, 2023DrugsFDA
AVKARE LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 384
Hazard: Failed impurities/degradation specifications: Out of specification for unknown impurities.
January 4, 2023DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE Gm
Hazard: Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
December 28, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Hazard: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
December 28, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Hazard: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
December 28, 2022DrugsFDA
Aurolife Pharma, LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08
Hazard: Failed Impurities/Degradation Specifications
December 28, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-1
Hazard: Presence of foreign substance
December 21, 2022DrugsFDA
Camber Pharmaceuticals, Inc recalls Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals
Hazard: Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
December 21, 2022DrugsFDA
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy recalls Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag la
Hazard: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
December 21, 2022DrugsFDA
Atlantic Management Resources Ltd. recalls Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen T
Hazard: cGMP Deviations
December 21, 2022DrugsFDA
Atlantic Management Resources Ltd. recalls ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc.
Hazard: cGMP Deviations
December 21, 2022DrugsFDA
Atlantic Management Resources Ltd. recalls Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen To
Hazard: cGMP Deviations
December 21, 2022DrugsFDA
Atlantic Management Resources Ltd. recalls Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for
Hazard: cGMP Deviations
December 21, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Hazard: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.