March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA,
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine,
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., Nort
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tra
Hazard: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
March 3, 2021DrugsFDA
Areva Pharmaceuticals Inc recalls Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Ph
Hazard: CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
March 3, 2021DrugsFDA
NDAL Mfg Inc. recalls ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distribut
Hazard: Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
March 3, 2021DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution,
Hazard: Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
March 3, 2021DrugsFDA
CareFusion 213, LLC recalls ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear
Hazard: Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
March 3, 2021DrugsFDA
CareFusion 213, LLC recalls ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-
Hazard: Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
March 3, 2021DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl.
Hazard: Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
February 24, 2021DrugsFDA
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Lt
Hazard: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
February 24, 2021DrugsFDA
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, L
Hazard: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
February 24, 2021DrugsFDA
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc recalls Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPH
Hazard: Failed Dissolution Specifications
February 24, 2021DrugsFDA
Wilshire Pharmaceuticals Inc recalls Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 3
Hazard: Failed Dissolution Specifications
February 24, 2021DrugsFDA
Wilshire Pharmaceuticals Inc recalls Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA
Hazard: Failed Dissolution Specifications
February 24, 2021DrugsFDA
DLC Laboratories, Inc recalls Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Divisi
Hazard: Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
February 24, 2021DrugsFDA
Liq-E S.A. De C.V. recalls OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico,
Hazard: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
February 24, 2021DrugsFDA
Liq-E S.A. De C.V. recalls OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V
Hazard: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
February 24, 2021DrugsFDA
Liq-E S.A. De C.V. recalls OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., P
Hazard: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
February 24, 2021DrugsFDA
Liq-E S.A. De C.V. recalls OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A.
Hazard: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
February 17, 2021DrugsFDA
Apotex Corp. recalls Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injec
Hazard: Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
February 17, 2021DrugsFDA
Apotex Corp. recalls Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection
Hazard: Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
February 17, 2021DrugsFDA
Stanley Specialty Pharmacy Compounding and Wellness Center recalls Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pha
Hazard: Superpotent Drug. Lidocaine higher concentration than listed
February 17, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. C
Hazard: Failed Impurity/Degradation Specifications
February 17, 2021DrugsFDA
Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Heal
Hazard: Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials