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Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Superpotent Drug: Product may not meet specifications throughout shelf life.

Eye Health Did You Hurt Your Eyes by Looking at the Solar Eclipse? ANDA: this is an unapproved drug that was also found to have subpotent assay results. BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. Labeling: Label Error on Declared Strength: Labeled 3.

No pending recalls for the November 6th, 2013 Enforcement Report. Pain Free by Nature, 1460 Masters Dr. All sterile products compounded by Specialty Medicine Compounding Pharmacy, South Lyon, MI. Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.

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Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp. Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc. Degradation Specifications: Out of specification for a known degradant.

Diese Datenbank, die seit 1996 im Internet verfügbar ist, bietet nun über 200. GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. 300 Shire Way, Lexington, MA 02421.

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N97969, N69175, N69177, N73763, Exp 03. Resuspension Problems: Recalled lot did not meet resuspendability requirements. Defective Delivery System: Some units have actuation counters set to a number other than 60. EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. Failed pH Specifications: confirmed out-of-specification results for pH.

5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Presence of Particulate Matter: various particulate matter found in the solution. Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded under the same conditions as another product found to be non-sterile and therefore sterility cannot be assured. UPC Codes: Blister Card 3 52544 28754 7. 5 mg C-IV, Rx Only, Mfd by: Mylan Pharmaceuticals Inc. Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

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Pleo Nota-Quent DROPS 5X, 10 mL bottles, NDC: 49807-0031-1. Rx only, Marketed by: Teva Neuroscience, Inc. Diluent Made in Italy, NDC 0008-1179-01.

Subpotent Drug: tetracaine is below specification at the 21 month stability test point. This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. 8 teaspoon was printed onto the primary label. 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc.

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Lake Forest, IL 60045, NDC 0409-1559-30. You have no items in your shopping cart. No pending recalls for the November 13th, 2013 Enforcement Report.

60 mg, 30 count bottle, Rx Only, manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, for: Teva Pharmaceuticals USA, Inc. Single-dose Vial, Rx only, Hospira, Inc. ADK-Kasting est en permanence à la recherche de talents. ANDA: FDA analysis found the products to contain undeclared sibutramine, a previously approved FDA product indicated for weight loss that was removed from the market for safety reasons, making these products unapproved new drugs. Lansoprazole Delayed Release Capsules, 15 mg 14 count. PL520, PL521, PL522 and PL523 Exp.

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Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc. MAGNESIUM Sulfate added to 100 mL 0. 5 mg, 100 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd. En vous inscrivant sur ce site, vous créez votre profil et le mettez à jour quand vous le souhaitez. Clinical trial volunteers play a important part in the development of medicines, medical devices, vaccines, etc.

Net Wt 80 grams per tube, Rx only, E. Please forward this error screen to 213. 50 mL, 50 mL Single-dose Fliptop Vial. L for Injection, 50 mL Vial, Rx Only, Not for Resale. Superpotent Drug: above specification for the assay.

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The Material in this site is intended to be of general informational use and is not intended to constitute medical advice, probable diagnosis, or recommended treatments. 3132593, 3132594, 3134420, 3134421, 3134422 Exp. Sibutramine was once a previously available FDA-approved drug used as an appetite suppressant for weight loss, that was withdrawn from the United States market in October 2010 for safety reasons, making this product an unapproved new drug. Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0. Important information related to the efficacy of the Phase 3 Second-Line Ovarian Carcinoma Study and adverse event information for Renal and Gastrointestinal systems for the recalled lots was observed to be missing from the package insert.

ANDA: FDA and New York State Department of Health analysis found these products to contain steroids or steroid-like substances, making them unapproved new drugs. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. ANDA: The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp.

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Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. Presence of Particulate Matter: particulate matter was found during the manufacturing process. Rx only, Distributed by Wyeth Pharmaceuticals Inc.

You have no items to compare. Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6. All unexpired lots of the above attached link of products. Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. Human Drug Product Recalls Pending ClassificationFDA is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public.

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3 mg, 10 mL Vial, Rx Only, Not for Resale. Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22. Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0. B-50 capsules, 100-count bottle, Healthy Life Chemistry By Purity First, Manufactured for: Purity First Health Products, Inc. Presence of Particulate Matter:The product may contain particulates from iron embedded in the glass container coming in contact with product solution.

Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8. ANDA: The product has been found to contain the undeclared active pharmaceutical ingredients Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin, making it an unapproved new drug. BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. Microbial Contamination of Non-Sterile Products: During routine QC monitoring of the firm’s environment, elevated counts of gram positive rods were recovered. Nystatin USP Powder 150 Million Units, Plastic, 19. FDA is now able to accomplish the goal of expedited notification within the Enforcement Report.

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Failed Dissolution Specification: exceeded specification rates for the 10 hour testing point. Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. 30 gram tube, Rx only, E. Fever acetaminophen oral suspension, Distributed By: Walgreen Co.

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx Only. North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4. Particulates consistent with glass delamination found in vials. FAZolin sodium added to 100 mL 0.