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FDA Drug Recalls

1,463 recalls · Class I, newest first

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 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

Class I · High risk Terminated Aug 21, 2015

fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC…

Reason Subpotent Drug

Cantrell Drug Company NDC 52533-214-45 D-1156-2016

Class I · High risk Terminated Aug 21, 2015

fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC…

Reason Subpotent Drug

Cantrell Drug Company D-1155-2016

Class I · High risk Terminated Aug 21, 2015

fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR ---…

Reason Subpotent Drug

Cantrell Drug Company D-1154-2016

Class I · High risk Terminated Aug 21, 2015

Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug…

Reason Subpotent Drug

Cantrell Drug Company NDC 52533-010-45 D-1153-2016

Class I · High risk Terminated Aug 21, 2015

fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little…

Reason Subpotent Drug

Cantrell Drug Company NDC 52533-024-45 D-1152-2016

Class I · High risk Terminated Aug 17, 2015

Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888

Reason Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.

Hartley Medical Center Pharmacy, Incorporated D-1830-2015

Class I · High risk Terminated Aug 17, 2015

Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial…

Reason Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.

Hartley Medical Center Pharmacy, Incorporated D-1829-2015

Class I · High risk Terminated Aug 6, 2015

KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC

Reason Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.

Blue Square Market, Inc. D-0297-2016

Class I · High risk Terminated Aug 6, 2015

LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali…

Reason Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

Blue Square Market, Inc. D-0296-2016

Class I · High risk Terminated Jul 24, 2015

ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva…

Reason Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution

Teva Pharmaceuticals USA NDC 0703-3019-12 D-1351-2015

Class I · High risk Terminated Jul 17, 2015

0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield…

Reason Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

Baxter Healthcare Corp. NDC 0338-0049-11 D-1336-2015

Class I · High risk Terminated Jul 17, 2015

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare…

Reason Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

Baxter Healthcare Corp. NDC 0338-0553-18 D-1335-2015

Class I · High risk Terminated Jul 17, 2015

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx…

Reason Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.

Pharmedium Services, LLC D-0093-2017

Class I · High risk Terminated Jun 12, 2015

PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and…

GC Natural Nutrition, Inc. D-1330-2015

Class I · High risk Terminated Jun 3, 2015

Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX…

Reason Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

Centro Naturista D-0878-2016

Class I · High risk Terminated Jun 3, 2015

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX…

Reason Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

Centro Naturista D-0877-2016

Class I · High risk Terminated May 22, 2015

Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%…

Reason Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

Pharmedium Services, LLC NDC 61553-401-44 D-0658-2016