🍔 Food 💊 Drugs 🏥 Medical Devices
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection. Class II

Reason: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

AnazaoHealth Corporation 20150126 Terminated
Distributed: Nationwide
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Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86 Class II

Reason: Failed Dissolution Specifications: 6 month time point.

Sun Pharma Global Fze 20150121 Terminated
Distributed: Nationwide.
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Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 . Class II

Reason: Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.

Akorn, Inc. 20150128 Terminated
Distributed: Nationwide
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Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8. Class II

Reason: Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

Taro Pharmaceuticals U.S.A., Inc. 20141230 Terminated
Distributed: Nationwide
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1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02. Class I

Reason: Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.

Hospira Inc. 20140418 Terminated
Distributed: Nationwide.
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Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30 Class II

Reason: Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Hospira Inc. 20141223 Terminated
Distributed: Nationwide
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Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446. Class II

Reason: Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

Baxter Healthcare Corp. 20141223 Terminated
Distributed: Nationwide, United Arab Emirates, and Columbia
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Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14. Class II

Reason: Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.

Valeant Pharmaceuticals North America LLC 20141231 Terminated
Distributed: Nationwide and Australia
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LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20 Class II

Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 20130926 Terminated
Distributed: Nationwide and Puerto Rico.
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CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20. Class II

Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 20130926 Terminated
Distributed: Nationwide and Puerto Rico.
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