November 8, 2017DrugsFDA
AVKARE Inc. recalls Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828
Hazard: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
November 1, 2017DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dis
Hazard: Cross contamination with other products: traces of Dapsone were found in the finished product.
November 1, 2017DrugsFDA
Vi-Jon, Inc. recalls Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR
Hazard: Failed Stability Specifications
November 1, 2017DrugsFDA
Aidarex Pharmaceuticals LLC recalls ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmac
Hazard: Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
November 1, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc.
Hazard: Failed Dissolution Specifications: Low out of specification results for dissolution.
November 1, 2017DrugsFDA
Wockhardt Usa Inc. recalls Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Ar
Hazard: Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC.
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LL
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC.
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only , Compounded by PharMEDium Services, LLC
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC.
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 1
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Ser
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium S
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Servic
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Ser
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Serv
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Ser
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Servi
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Serv
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
Pharmedium Services, LLC recalls Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Se
Hazard: Subpotent Drug
November 1, 2017DrugsFDA
AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: A
Hazard: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
November 1, 2017DrugsFDA
AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump
Hazard: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
November 1, 2017DrugsFDA
Vitility recalls MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, Ca
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
November 1, 2017DrugsFDA
Lucky Mart Inc. recalls PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., L
Hazard: Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
November 1, 2017DrugsFDA
Baxter Healthcare Corporation recalls Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter
Hazard: Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
November 1, 2017DrugsFDA
Becton Dickinson & Company recalls ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator,
Hazard: Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 73
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detro
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detro
Hazard: Lack of Assurance of Sterility.