August 23, 2017DrugsFDA
KVK-Tech, Inc. recalls Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC
Hazard: Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
August 16, 2017DrugsFDA
HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0
Hazard: Presence of Particulate Matter: Silicone oil
August 16, 2017DrugsFDA
HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per ca
Hazard: Presence of Particulate Matter: Silicone oil
August 16, 2017DrugsFDA
HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral M
Hazard: Presence of Particulate Matter: Silicone oil
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 73
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Compa
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 C
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Com
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Ro
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell D
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Com
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug C
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 C
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Compa
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
Cantrell Drug Company recalls Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Compa
Hazard: Lack of Sterility Assurance.
August 16, 2017DrugsFDA
AtHome Medical, Inc. recalls Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485
Hazard: GMP Deviations: The firm does not include an SOP for testing for out of specifications.
August 16, 2017DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Hazard: Presence of Foreign Substance: potential presence of plastic particles.
August 16, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx onl
Hazard: Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
August 9, 2017DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC
Hazard: Failed Tablet/Capsule Specification: out of specification for tablet weight.
August 9, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA
Hazard: Failed Tablet/Capsule Specification; out of specification for tablet weight
August 9, 2017DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Mich
Hazard: Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
August 9, 2017DrugsFDA
Vi-Jon, Inc. recalls Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium
Hazard: Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
August 9, 2017DrugsFDA
VistaPharm, Inc. recalls Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by Vist
Hazard: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.