January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded in
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded inj
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable dru
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx onl
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectabl
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug;
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug;
Hazard: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
January 3, 2018DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Mo
Hazard: Failed Stability Specifications
January 3, 2018DrugsFDA
Simple Diagnostics, Inc. recalls Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Wins
Hazard: Lack of Assurance of Sterility and cGMP Deviations
January 3, 2018DrugsFDA
Keryx Biopharmaceuticals, Inc. recalls Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopha
Hazard: Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
January 3, 2018DrugsFDA
Pharmedium Services, LLC recalls HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded
Hazard: Labeling: Incorrect or Missing Lot and/or Exp. Date
January 3, 2018DrugsFDA
Pharmedium Services, LLC recalls morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: P
Hazard: Labeling: Incorrect or Missing Lot and/or Exp. Date
January 3, 2018DrugsFDA
Pharmedium Services, LLC recalls morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only,
Hazard: Labeling: Incorrect or Missing Lot and/or Exp. Date
December 27, 2017DrugsFDA
Vital Rx, Inc. dba Atlantic Pharmacy and Compounding recalls All Sterile Products within expiry
Hazard: Lack of Assurance of Sterility .
December 27, 2017DrugsFDA
Premier Pharmacy Labs Inc recalls Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded
Hazard: Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
December 27, 2017DrugsFDA
L. Perrigo Company recalls Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distri
Hazard: Microbial Contamination of Non-Sterile Products
December 27, 2017DrugsFDA
Claris Lifesciences Inc recalls Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Ma
Hazard: Superpotent
December 27, 2017DrugsFDA
The Ampt Life, LLC recalls NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactu
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
December 27, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx o
Hazard: Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
December 27, 2017DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactur
Hazard: Superpotent
December 27, 2017DrugsFDA
Pfizer Inc. recalls Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA.
Hazard: Presence of Particulate Matter: glass particulate found in vial
December 27, 2017DrugsFDA
EZWeightLossTX LLC recalls LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
Hazard: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
December 27, 2017DrugsFDA
EZWeightLossTX LLC recalls LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
Hazard: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
December 27, 2017DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ
Hazard: Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged
Hazard: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packa
Hazard: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5
Hazard: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.