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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 12601–12620 of 17,816 recalls

Class IIOngoing

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

Hospira, Inc.

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

August 25, 2015 · DrugView details →

Class IITerminated

Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.

Apotex Inc.

Lack of Assurance of Sterility: Failed preservative effectiveness testing

August 25, 2015 · DrugView details →

Class ITerminated

Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class IITerminated

Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612.

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

August 24, 2015 · DrugView details →

Class IITerminated

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

August 24, 2015 · DrugView details →

Class IITerminated

Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)

C. O. Truxton

Labeling: Wrong Bar Code

August 24, 2015 · DrugView details →

Class IITerminated

BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

August 24, 2015 · DrugView details →

Class ITerminated

Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class IITerminated

Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3.

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

August 24, 2015 · DrugView details →

Class ITerminated

Xcellerator (product not labeled)

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

TruTrim (product not labeled)

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

Class ITerminated

Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.

Novacare, LLC

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

August 24, 2015 · DrugView details →

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