🍔 Food 💊 Drugs 🏥 Medical Devices
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.

Bethel Nutritional Consulting, Inc 20130611 Terminated
Distributed: Nationwide. Product was also available for sale via internet
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Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50 Class I

Reason: Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.

Fresenius Kabi USA, LLC 20130525 Terminated
Distributed: Nationwide
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ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9. Class I

Reason: Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

Advance Pharmaceutical Inc 20130617 Terminated
Distributed: Nationwide
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Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA Class II

Reason: Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes

Clinical Specialties Compounding Pharmacy 20130311 Terminated
Distributed: FL, GA, IN, LA and SC.
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buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. Class III

Reason: Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

Actavis South Atlantic LLC 20130821 Terminated
Distributed: Nationwide and Puerto Rico
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CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110. Class II

Reason: cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy

Medicis Pharmaceutical Corp 20130501 Terminated
Distributed: Nationwide, Great Britain, Mexico, Russia and The Ukraine.
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IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7. Class II

Reason: Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

Fresenius Kabi USA LLC (FK USA) 20130122 Terminated
Distributed: Nationwide
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Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53 Class III

Reason: Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Bracco Diagnostics Inc 20130719 Terminated
Distributed: Nationwide
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Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 Class II

Reason: Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.

VistaPharm, Inc. 20130704 Terminated
Distributed: Nationwide.
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Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR Class II

Reason: Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products

Earthlabs, Inc. DBA Wise Woman Herbals 20130527 Terminated
Distributed: Nationwide
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