🍔 Food 💊 Drugs 🏥 Medical Devices
SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135. Class II

Reason: Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory

Apothecary Shoppe 20130906 Terminated
Distributed: Oklahoma
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Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135. Class II

Reason: Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.

Apothecary Shoppe 20130906 Terminated
Distributed: Oklahoma
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5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01 Class II

Reason: Presence of Particulate Matter; report of visible particulates in the glass ampule

Hospira Inc. 20130829 Terminated
Distributed: Nationwide
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Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518. Class II

Reason: Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Triangle Compounding 20130906 Terminated
Distributed: NC
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Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518. Class II

Reason: Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Triangle Compounding 20130906 Terminated
Distributed: NC
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Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA. Class III

Reason: Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Osmotica Pharmaceutical Corp 20130916 Terminated
Distributed: Nationwide
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Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22 Class II

Reason: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

AmeriSource Bergen 20130913 Terminated
Distributed: Nationwide
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Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 Class II

Reason: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

AmeriSource Bergen 20130913 Terminated
Distributed: Nationwide
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Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8. Class II

Reason: CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.

Marlex Pharmaceuticals, Inc. 20130808 Terminated
Distributed: Nationwide.
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Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX. Class II

Reason: Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

Walgreens Co 20130823 Terminated
Distributed: Nationwide
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