August 24, 2022DrugsFDA
Akorn, Inc recalls PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 1170
Hazard: Defective Container: Product has incomplete induction seals.
August 24, 2022DrugsFDA
Aire-Master of America Inc recalls Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka H
Hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
August 24, 2022DrugsFDA
Aire-Master of America Inc recalls Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard,
Hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
August 24, 2022DrugsFDA
Aire-Master of America Inc recalls Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Prot
Hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
August 24, 2022DrugsFDA
Aire-Master of America Inc recalls Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporat
Hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
August 24, 2022DrugsFDA
Aire-Master of America Inc recalls Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Bra
Hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
August 24, 2022DrugsFDA
Aire-Master of America Inc recalls Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon
Hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
August 24, 2022DrugsFDA
Nephron Sc Inc recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharma
Hazard: cGMP Deviations: deviations leading to potential cross-contamination.
August 24, 2022DrugsFDA
Akron Pharma, Inc. recalls Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (
Hazard: Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
August 24, 2022DrugsFDA
Akron Pharma, Inc. recalls Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024
Hazard: Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
August 24, 2022DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufa
Hazard: Failed Impurities/Degradation Specifications
August 24, 2022DrugsFDA
Amerisource Health Services LLC recalls Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceutical
Hazard: Subpotent Drug
August 24, 2022DrugsFDA
Baxter Healthcare Corporation recalls Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous
Hazard: Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore,
Hazard: CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
August 24, 2022DrugsFDA
MEDEK LLC recalls M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kos
Hazard: Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
August 24, 2022DrugsFDA
HERON THERAPEUTICS, INC. recalls Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit,
Hazard: Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
August 17, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint La
Hazard: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
August 17, 2022DrugsFDA
SterRx, LLC recalls fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue,
Hazard: Lack of Assurance of Sterility
August 17, 2022DrugsFDA
SterRx, LLC recalls FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Platt
Hazard: Lack of Assurance of Sterility
August 17, 2022DrugsFDA
Strides Pharma Inc. recalls Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 5621
Hazard: Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
August 17, 2022DrugsFDA
AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 4229
Hazard: Labeling: Label Error on Declared Strength
August 17, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., Ind
Hazard: Lack of Assurance of Sterility: Complaints received of defective container closure.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962,
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free
Hazard: CGMP Deviations: products were stored outside the drug label specifications.
August 17, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent a
Hazard: CGMP Deviations: products were stored outside the drug label specifications.