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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

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

Axcentria Pharmaceuticals

Class I - Dangerous

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

May 5, 2014 Other Drugs Nationwide View Details →

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

Hospira

Class I - Dangerous

Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.

Jun 27, 2014 Prescription Drugs Nationwide View Details →

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

Teva Pharmaceuticals USA

Class I - Dangerous

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

Jun 17, 2014 Prescription Drugs Nationwide View Details →

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.

Fougera Pharmaceuticals

Class I - Dangerous

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

Jul 3, 2014 Prescription Drugs Nationwide View Details →

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

Teva Pharmaceuticals USA

Class I - Dangerous

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

Jun 17, 2014 Prescription Drugs Nationwide View Details →

Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02

Fresenius Kabi USA

Class I - Dangerous

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

May 2, 2014 Prescription Drugs Nationwide View Details →

Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709

United Therapeutics

Class I - Dangerous

Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

Mar 28, 2014 Prescription Drugs View Details →

BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.

Healix Infusion Therapy

Class I - Dangerous

Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.

Feb 13, 2014 Other Drugs View Details →

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

Hospira

Class I - Dangerous

Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

May 16, 2014 Prescription Drugs Nationwide View Details →

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10

Fresenius Kabi USA

Class I - Dangerous

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

May 2, 2014 Prescription Drugs Nationwide View Details →

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62

Hospira

Class I - Dangerous

Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.

Jun 6, 2014 Prescription Drugs Nationwide View Details →

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.

May 29, 2014 Prescription Drugs Nationwide View Details →

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

Boehringer Ingelheim Roxane

Class I - Dangerous

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

May 1, 2014 Prescription Drugs Nationwide View Details →

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

Ferring Pharmaceuticals

Class I - Dangerous

Discoloration; due to prolonged heat exposure.

Sep 19, 2013 Prescription Drugs Nationwide View Details →

Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Brookfield Prescription Center Inc.

Class I - Dangerous

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

May 30, 2014 Prescription Drugs View Details →

HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Brookfield Prescription Center Inc.

Class I - Dangerous

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

May 30, 2014 Prescription Drugs View Details →

HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Brookfield Prescription Center Inc.

Class I - Dangerous

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

May 30, 2014 Prescription Drugs View Details →

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.

Caraco Pharmaceutical Laboratories

Class I - Dangerous

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Jun 12, 2014 Prescription Drugs Nationwide View Details →

Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

Brookfield Prescription Center Inc.

Class I - Dangerous

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

May 30, 2014 Prescription Drugs View Details →

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

West-Ward Pharmaceutical

Class I - Dangerous

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

May 20, 2014 Prescription Drugs Nationwide View Details →