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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 15381–15400 of 17,832 recalls

Class IITerminated

Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

Compounding Centre At Blue Ridge

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

October 18, 2013 · DrugView details →
Class ITerminated

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

Hospira Inc.

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

October 18, 2013 · Drug
View details →
Class IIITerminated

Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.

Taro Pharmaceuticals U.S.A., Inc.

Subpotent. drug

October 16, 2013 · DrugView details →
Class ITerminated

Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11

B. Braun Medical Inc

Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.

October 15, 2013 · DrugView details →
Class IITerminated

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

VistaPharm, Inc.

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

October 15, 2013 · DrugView details →
Class IITerminated

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)

Teva Pharmaceuticals USA

Presence of Precipitate; precipitation of drug product

October 11, 2013 · DrugView details →
Class IITerminated

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

Hospira Inc.

Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

October 11, 2013 · DrugView details →
Class IITerminated

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

Sandoz Inc

Subpotent; Hydrochlorothiazide at the 9 month time point.

October 11, 2013 · DrugView details →
Class IITerminated

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Hospira Inc.

Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.

October 11, 2013 · DrugView details →
Class ITerminated

Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Pure Edge Nutrition

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

October 10, 2013 · DrugView details →
Class ITerminated

Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Pure Edge Nutrition

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

October 10, 2013 · DrugView details →
Class IITerminated

Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009

Airgas Medical Services

Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

October 10, 2013 · DrugView details →
Class ITerminated

Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Pure Edge Nutrition

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

October 10, 2013 · DrugView details →
Class ITerminated

Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Pure Edge Nutrition

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

October 10, 2013 · DrugView details →
Class ITerminated

Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Pure Edge Nutrition

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

October 10, 2013 · DrugView details →
Class ITerminated

Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Pure Edge Nutrition

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

October 10, 2013 · DrugView details →
Class IITerminated

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Actavis Elizabeth LLC

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

October 9, 2013 · DrugView details →
Class IITerminated

Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92

Sandoz, Inc

Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.

October 9, 2013 · DrugView details →
Class ITerminated

Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.

B @ B Trade Inc.

Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine

October 7, 2013 · DrugView details →
Class IITerminated

Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09

Amedra Pharmaceuticals LLC

Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

October 7, 2013 · DrugView details →
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