February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Adenosine Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Succinylcholine Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Lidocaine HCl in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Aurobindo Pharma Ltd. recalls Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc.
Hazard: Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
February 21, 2018DrugsFDA
The Compounding Pharmacy of America recalls HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compou
Hazard: Non-Sterility
February 21, 2018DrugsFDA
AMERICAN HEALTH PACKAGING recalls Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7
Hazard: CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
February 21, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerus
Hazard: Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
February 21, 2018DrugsFDA
PharMEDium Services, LLC recalls 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Hazard: Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
February 21, 2018DrugsFDA
PharMEDium Services, LLC recalls 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium S
Hazard: Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
February 21, 2018DrugsFDA
PharMEDium Services, LLC recalls 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Hazard: Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
February 21, 2018DrugsFDA
Webrx dba RxPalace.com recalls BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by Web
Hazard: CGMP Deviations: not manufactured according to current good manufacturing practices.
February 21, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical
Hazard: Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
February 21, 2018DrugsFDA
Genentech, Inc. recalls Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Mem
Hazard: Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
February 21, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08
Hazard: Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
February 21, 2018DrugsFDA
BYL Solutions Inc. recalls Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba
Hazard: Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
February 21, 2018DrugsFDA
ALLERGAN recalls NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by:
Hazard: Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.