IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA. Class II

Reason: Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Dr. Reddy's Laboratories, Inc. 20130829 Terminated
Distributed: Nationwide (& Puerto Rico)
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Class II

Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Leiter's Pharmacy 20130826 Terminated
Distributed: Nationwide
Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Class II

Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.

Leiter's Pharmacy 20130826 Terminated
Distributed: Nationwide
Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Class II

Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Leiter's Pharmacy 20130826 Terminated
Distributed: Nationwide
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 Class II

Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Leiter's Pharmacy 20130826 Terminated
Distributed: Nationwide
SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, 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
SODIUM BICARBONATE PF 8.4% INJECTABLE, 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
SERMORELIN ACETATE 10 MG INJECTABLE, 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
SELENIUM 400 MCG/ML INJECTABLE, 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
QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, 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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