July 18, 2018DrugsFDA
Sanofi-Aventis U.S. LLC recalls Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per
Hazard: Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
July 18, 2018DrugsFDA
Medi-Fare Drug and Home Health Center recalls Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Com
Hazard: CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
July 18, 2018DrugsFDA
SCA Pharmaceuticals recalls Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total
Hazard: Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
July 18, 2018DrugsFDA
Medgyn Products, Inc. recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Ma
Hazard: CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
July 18, 2018DrugsFDA
Akorn, Inc. recalls Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 1747
Hazard: CGMP Deviations
July 18, 2018DrugsFDA
AMERICAN HEALTH PACKAGING recalls Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distri
Hazard: Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
July 18, 2018DrugsFDA
Wockhardt Limited recalls Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 des
Hazard: Failed Impurities/Degradation Specifications
July 18, 2018DrugsFDA
Wockhardt Limited recalls Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desic
Hazard: Failed Impurities/Degradation Specifications
July 18, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, I
Hazard: Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
July 11, 2018DrugsFDA
Fagron Compounding Services LLC dba Fagron Sterile Services recalls Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package
Hazard: Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
July 11, 2018DrugsFDA
Fagron Compounding Services LLC dba Fagron Sterile Services recalls Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package
Hazard: Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
July 11, 2018DrugsFDA
Eb5 Corporation recalls eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton conta
Hazard: Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
July 11, 2018DrugsFDA
LUPIN SOMERSET recalls Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (ND
Hazard: Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, W
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
SCA Pharmaceuticals, LLC recalls Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Hazard: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
July 11, 2018DrugsFDA
Qualgen, LLC recalls TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 7
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date.
July 11, 2018DrugsFDA
Qualgen, LLC recalls ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013.
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date.
July 11, 2018DrugsFDA
Ingenus Pharmaceuticals Llc recalls Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: In
Hazard: Superpotent Drug: High out of specification assay value results for potency.
July 11, 2018DrugsFDA
Ingenus Pharmaceuticals Llc recalls Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: I
Hazard: Superpotent Drug: High out of specification assay value results for potency.
July 4, 2018DrugsFDA
Advanced Pharma Inc. recalls fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma
Hazard: Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.