🍔 Food 💊 Drugs 🏥 Medical Devices
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70 Class III

Reason: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.

Pfizer Inc. 20140708 Terminated
Distributed: Nationwide and Puerto Rico
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ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. Class II

Reason: Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

CareFusion 213, LLC 20130613 Terminated
Distributed: Nationwide in U.S.
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Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60. Class III

Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Fougera Pharmaceuticals Inc. 20140703 Terminated
Distributed: Nationwide
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Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60. Class III

Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Fougera Pharmaceuticals Inc. 20140703 Terminated
Distributed: Nationwide
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Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 Class III

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA 20140617 Terminated
Distributed: Nationwide
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Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58 Class III

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA 20140617 Terminated
Distributed: Nationwide
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Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58 Class III

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA 20140617 Terminated
Distributed: Nationwide
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Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 Class III

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA 20140617 Terminated
Distributed: Nationwide
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Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08. Class III

Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 20140703 Terminated
Distributed: Nationwide, Puerto Rico, and Guam.
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Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA Class II

Reason: Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

Axcentria Pharmaceuticals, LLC 20140505 Terminated
Distributed: Nationwide
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