April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-0
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-0
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, N
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) a
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx on
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
Azurity Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and
Hazard: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
April 5, 2023DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd.,
Hazard: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
April 5, 2023DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,
Hazard: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
April 5, 2023DrugsFDA
Apollo Care recalls Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only,
Hazard: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC619
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: D
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: D
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By:
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Endo Pharmaceuticals, Inc. recalls Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7
Hazard: Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
March 29, 2023DrugsFDA
Global Pharma Healthcare Private Limited recalls Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed B
Hazard: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
March 29, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited,
Hazard: Failed Content Uniformity Specifications
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.