🍔 Food 💊 Drugs 🏥 Medical Devices
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 Class II

Reason: Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

Janssen Ortho L.L.C. 20140917 Terminated
Distributed: Nationwide
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Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09. Class II

Reason: Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Mckesson 20140912 Terminated
Distributed: McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
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AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. Class I

Reason: Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Eugene Oregon, Inc. 20140505 Terminated
Distributed: To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
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Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9. Class II

Reason: Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Actavis Laboratories, FL, Inc. 20140424 Terminated
Distributed: Nationwide and Puerto Rico
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Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Class II

Reason: Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Actavis Laboratories, FL, Inc. 20140424 Terminated
Distributed: Nationwide and Puerto Rico
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Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82 Class II

Reason: Lack of Assurance of Sterility; leaking of premix bags

Sagent Pharmaceuticals Inc 20140304 Terminated
Distributed: Nationwide
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MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 Class I

Reason: Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Eugene Oregon, Inc. 20140505 Terminated
Distributed: To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
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Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd. Class I

Reason: Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Eugene Oregon, Inc. 20140505 Terminated
Distributed: To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
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CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07. Class II

Reason: Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

AbbVie Inc 20140915 Terminated
Distributed: US: Nationwide
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Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05. Class I

Reason: Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Baxter Healthcare Corp. 20140807 Terminated
Distributed: Nationwide
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