🍔 Food 💊 Drugs 🏥 Medical Devices
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01. Class II

Reason: Failed Tablet/Capsule Specifications; Product contains broken tablets.

Watson Laboratories Inc 20140115 Terminated
Distributed: Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
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Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244 Class I

Reason: Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

NuVision Pharmacy, Inc. 20130415 Terminated
Distributed: Nationwide
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HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 Class I

Reason: Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

NuVision Pharmacy, Inc. 20130415 Terminated
Distributed: Nationwide
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Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com Class I

Reason: Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug

IQ Formulations, LLC 20131104 Terminated
Distributed: Nationwide, Hawaii and Puerto Rico
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Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Class I

Reason: Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

Alexion Pharmaceuticals, Inc. 20131104 Terminated
Distributed: Nationwide, Puerto Rico, Jamaica, and Grenada.
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Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501. Class II

Reason: Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

Humco Holding Group, Inc 20131126 Terminated
Distributed: Nationwide
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eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6. Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b

SS Wholesale Inc. dba Jobbers Wholesale 20131118 Terminated
Distributed: CA
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MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2. Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved

SS Wholesale Inc. dba Jobbers Wholesale 20131118 Terminated
Distributed: CA
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Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3. Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by

SS Wholesale Inc. dba Jobbers Wholesale 20131118 Terminated
Distributed: CA
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KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9. Class III

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

Fougera Pharmaceuticals Inc. 20131118 Terminated
Distributed: Nationwide and Puerto Rico
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