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FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated Aug 24, 2015

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…

Reason Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the…

Allergan Sales, LLC NDC 0023-0240-04 D-1818-2015

Class II · Moderate risk Terminated Aug 24, 2015

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)…

Reason Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the…

Allergan Sales, LLC NDC 0023-0312-04 D-1817-2015

Class I · High risk Terminated Aug 24, 2015

Xcellerator (product not labeled)

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

Novacare, LLC D-0973-2016

Class I · High risk Terminated Aug 24, 2015

Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers…

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

Novacare, LLC D-0972-2016

Class I · High risk Terminated Aug 24, 2015

Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma…

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

Novacare, LLC D-0971-2016

Class I · High risk Terminated Aug 24, 2015

Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma…

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

Novacare, LLC D-0970-2016

Class I · High risk Terminated Aug 24, 2015

Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38…

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

Novacare, LLC D-0969-2016

Class I · High risk Terminated Aug 24, 2015

Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs…

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

Novacare, LLC D-0968-2016

Class I · High risk Terminated Aug 24, 2015

TruTrim (product not labeled)

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

Novacare, LLC D-0967-2016

Class I · High risk Terminated Aug 24, 2015

The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store…

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

Novacare, LLC D-0966-2016

Class I · High risk Terminated Aug 24, 2015

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

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

Novacare, LLC D-0965-2016

Class I · High risk Terminated Aug 24, 2015

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

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

Novacare, LLC D-0964-2016

Class I · High risk Terminated Aug 24, 2015

Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade…

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

Novacare, LLC D-0963-2016

Class I · High risk Terminated Aug 24, 2015

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

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

Novacare, LLC D-0962-2016

Class I · High risk Terminated Aug 24, 2015

Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg…

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

Novacare, LLC D-0961-2016

Class II · Moderate risk Terminated Aug 24, 2015

Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031…

Reason Labeling: Wrong Bar Code

C. O. Truxton NDC 0463-6000-50 D-0164-2016

Class III · Low risk Terminated Aug 21, 2015

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18)…

Silarx Pharmaceutical, Inc. NDC 54838-0566-70 D-1416-2015

Class II · Moderate risk Terminated Aug 21, 2015

MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock…

Reason Subpotent Drug

Cantrell Drug Company NDC 52533-001-16 D-1164-2016

Class II · Moderate risk Terminated Aug 21, 2015

MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721

Reason Subpotent Drug

Cantrell Drug Company D-1163-2016

Class II · Moderate risk Terminated Aug 21, 2015

Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little…

Reason Subpotent Drug

Cantrell Drug Company NDC 52533-157-45 D-1162-2016

Class II · Moderate risk Terminated Aug 21, 2015

LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock…

Reason Subpotent Drug

Cantrell Drug Company D-1161-2016

Class II · Moderate risk Terminated Aug 21, 2015

HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC…

Reason Stability Data Does Not Support Expiry

Cantrell Drug Company NDC 52533-148-16 D-1160-2016

Class II · Moderate risk Terminated Aug 21, 2015

HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC…

Reason Stability Data Does Not Support Expiry

Cantrell Drug Company D-1159-2016

Class I · High risk Terminated Aug 21, 2015

fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR…

Reason Subpotent Drug

Cantrell Drug Company NDC 52533-074-16 D-1158-2016

Class I · High risk Terminated Aug 21, 2015

fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR ---…

Reason Subpotent Drug

Cantrell Drug Company D-1157-2016