February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
LGM Pharma LLC recalls CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, F
Hazard: CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
February 20, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL In
Hazard: Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
February 20, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.
Hazard: Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
February 20, 2019DrugsFDA
Akorn Inc recalls COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx
Hazard: Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
February 20, 2019DrugsFDA
US Compounding Inc recalls LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compoun
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harb
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm H
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Spe
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Har
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harb
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harb
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25m
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy
Hazard: Lack of sterility assurance.
February 20, 2019DrugsFDA
Promise Pharmacy, LLC recalls HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy
Hazard: Lack of sterility assurance.