July 13, 2022DrugsFDA
Wedgewood Village Pharmacy, LLC recalls Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Hero
Hazard: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
July 13, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd
Hazard: CGMP Deviations
July 13, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd
Hazard: CGMP Deviations
July 13, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.
Hazard: CGMP Deviations
July 13, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Lt
Hazard: CGMP Deviations
July 13, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Indus
Hazard: CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
July 13, 2022DrugsFDA
Vi-Jon, LLC recalls CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: C
Hazard: Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
July 13, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plai
Hazard: Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
July 13, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-3
Hazard: Defective Container
July 6, 2022DrugsFDA
Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by:
Hazard: Defective container: defect prevents product from dispensing as intended.
July 6, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141,
Hazard: CGMP Deviations
July 6, 2022DrugsFDA
Akorn, Inc. recalls Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHA
Hazard: Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
July 6, 2022DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Man
Hazard: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
July 6, 2022DrugsFDA
Akcea Therapeutics, Inc. recalls Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each
Hazard: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
July 6, 2022DrugsFDA
Green Pharmaceuticals, Inc. recalls SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 291
Hazard: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
July 6, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-1
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
July 6, 2022DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, In
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
July 6, 2022DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
July 6, 2022DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
July 6, 2022DrugsFDA
Buzzagogo, LLC recalls Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116
Hazard: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
June 29, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC
Hazard: Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
June 29, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd.
Hazard: Failed Tablet/Capsule Specification; oversized tablet found in a bottle
June 29, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmac
Hazard: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
June 29, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmac
Hazard: CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
June 29, 2022DrugsFDA
Mayne Pharma Inc recalls Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufac
Hazard: Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
June 29, 2022DrugsFDA
Vi-Jon, LLC recalls 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medli
Hazard: Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
June 22, 2022DrugsFDA
Walmart Inc recalls Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC
Hazard: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
June 22, 2022DrugsFDA
Walmart Inc recalls Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705.
Hazard: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
June 22, 2022DrugsFDA
Walmart Inc recalls Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion
Hazard: Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
June 22, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Balt
Hazard: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.