🍔 Food 💊 Drugs 🏥 Medical Devices
SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Class II

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Beacon Hill Medical Pharmacy, P.C. 20130726 Terminated
Distributed: USA nationwide
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Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ Class I

Reason: Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug

Beamonstar Products 20130501 Terminated
Distributed: US states nationwide and international.
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SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ Class I

Reason: Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug

Beamonstar Products 20130501 Terminated
Distributed: US states nationwide and international.
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CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11 Class II

Reason: Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Teva Pharmaceuticals USA, Inc. 20130813 Terminated
Distributed: Nationwide
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Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12 Class II

Reason: Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Hospira Inc. 20130816 Terminated
Distributed: Nationwide and Puerto Rico
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Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 Class II

Reason: Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

Hospira, Inc. 20130812 Terminated
Distributed: Naitonwide
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Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02 Class II

Reason: Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.

Nexus Pharmaceuticals Inc 20130801 Terminated
Distributed: Nationwide
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Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03 Class II

Reason: Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.

Teva Pharmaceuticals USA, Inc. 20130806 Terminated
Distributed: Nationwide
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Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3. Class II

Reason: Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.

Novocol Pharmaceutical of Canada 20130814 Terminated
Distributed: Nationwide and Canada
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0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 Class I

Reason: Presence of Particulate Matter; product may contain fibrous material

Hospira Inc. 20120831 Terminated
Distributed: Nationwide
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