September 27, 2017DrugsFDA
Amgen, Inc. recalls Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25
Hazard: Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Pfizer Inc. recalls Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx o
Hazard: Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
September 27, 2017DrugsFDA
Pfizer Inc. recalls HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc.,
Hazard: Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
September 27, 2017DrugsFDA
PharMedium Services, Llc recalls Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag i
Hazard: Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
September 27, 2017DrugsFDA
PharMedium Services, Llc recalls Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag i
Hazard: Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
September 27, 2017DrugsFDA
Pfizer Inc. recalls Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted wit
Hazard: Failed Dissolution Specifications
September 27, 2017DrugsFDA
Pfizer Inc. recalls Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted wi
Hazard: Failed Dissolution Specifications
September 20, 2017DrugsFDA
Aidarex Pharmaceuticals LLC recalls Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-
Hazard: Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, I
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 6065
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Bella Pharmaceuticals, Inc. recalls PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
Hazard: Lack of Assurance of Sterility.
September 20, 2017DrugsFDA
Chiavna Saffron LLC recalls Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6
Hazard: Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
September 20, 2017DrugsFDA
BESTHERBS COFFEE LLC recalls New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Mad
Hazard: Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.