March 31, 2021DrugsFDA
Adams.Secret.co recalls Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 4346
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
March 24, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Hazard: Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
March 24, 2021DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
March 24, 2021DrugsFDA
Edge Pharma, LLC recalls Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.7
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
March 24, 2021DrugsFDA
Edge Pharma, LLC recalls Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharm
Hazard: Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
March 24, 2021DrugsFDA
Sagent Pharmaceuticals Inc recalls Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per ca
Hazard: Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
March 24, 2021DrugsFDA
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Phi
Hazard: Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
March 24, 2021DrugsFDA
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629
Hazard: Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
March 24, 2021DrugsFDA
Akorn, Inc. recalls Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only,
Hazard: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
March 24, 2021DrugsFDA
Direct Rx recalls Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonv
Hazard: cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
March 17, 2021DrugsFDA
Ferring Pharmaceuticals Inc recalls Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single do
Hazard: Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
March 10, 2021DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, In
Hazard: Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
March 10, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceutica
Hazard: Chemical contamination; Unknown brown residue adhering to the inside of one vial.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sea
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sea
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foi
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-s
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc
Hazard: Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
March 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-
Hazard: Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
March 10, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-High
Hazard: Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
March 10, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx
Hazard: Subpotent
March 3, 2021DrugsFDA
The General Hospital Corporation recalls Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufacture
Hazard: Lack of Assurance of Sterility
March 3, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 3
Hazard: Failed Dissolution Specifications
March 3, 2021DrugsFDA
Meitheal Pharmaceuticals Inc recalls Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x
Hazard: Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
March 3, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA
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, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pha
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, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Phar
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, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva P
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, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25
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, 1.5 mg/vial (1,500,000 ng), 10 mL 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.