🍔 Food 💊 Drugs 🏥 Medical Devices
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA. Class I

Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.

Nature's Universe 20140409 Terminated
Distributed: U.S. Nationwide and Canada
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Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822. Class I

Reason: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Baxter Healthcare Corp. 20140711 Terminated
Distributed: Nationwide, Puerto Rico, Singapore, and Hong Kong
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0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043. Class I

Reason: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Baxter Healthcare Corp. 20140711 Terminated
Distributed: Nationwide, Puerto Rico, Singapore, and Hong Kong
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0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Class I

Reason: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Baxter Healthcare Corp. 20140711 Terminated
Distributed: Nationwide, Puerto Rico, Singapore, and Hong Kong
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Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01 Class I

Reason: Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.

American Health Packaging 20140701 Terminated
Distributed: Nationwide and Puerto Rico
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Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01 Class I

Reason: Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544

American Health Packaging 20140701 Terminated
Distributed: Nationwide and Puerto Rico
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Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02 Class II

Reason: Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

Hospira Inc. 20140904 Terminated
Distributed: Nationwide
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NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 Class II

Reason: Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.

Unique Pharmaceutical, Ltd 20130417 Terminated
Distributed: TN, PA, and TX
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Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA Class II

Reason: Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.

Solace International Inc 20140828 Terminated
Distributed: Amazon US and Amazon UK
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Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA Class II

Reason: Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.

Solace International Inc 20140828 Terminated
Distributed: Amazon US and Amazon UK
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