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FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk Terminated Mar 11, 2015

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045…

Reason Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently…

Hospira Inc. NDC 0409-7828-08 D-1108-2015

Class I · High risk Terminated Mar 10, 2015

ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico…

Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein

Ultra ZX Supplements D-0991-2015

Class I · High risk Terminated Mar 6, 2015

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as…

Hospira Inc. NDC 0409-6727-23 D-1076-2015

Class I · High risk Terminated Mar 5, 2015

0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.

Reason Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.

Hospira Inc. NDC 0409-7983-25 D-0976-2015

Class I · High risk Terminated Jan 28, 2015

PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-149-50 D-1828-2015

Class I · High risk Terminated Jan 28, 2015

PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-236-50 D-1827-2015

Class I · High risk Terminated Jan 28, 2015

PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-156-50 D-1826-2015

Class I · High risk Terminated Jan 28, 2015

Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-107-50 D-1825-2015

Class I · High risk Terminated Jan 28, 2015

Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-181-50 D-1824-2015

Class I · High risk Terminated Jan 28, 2015

Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-197-50 D-1823-2015

Class I · High risk Terminated Jan 28, 2015

PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-169-50 D-1822-2015

Class I · High risk Terminated Jan 28, 2015

PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only…

Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due…

Pharmedium Services, LLC NDC 61553-171-50 D-1821-2015

Class I · High risk Terminated Jan 25, 2015

iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC…

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.

Detox Transforms D-0981-2015

Class I · High risk Terminated Jan 25, 2015

BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.

Detox Transforms D-0980-2015

Class I · High risk Terminated Jan 25, 2015

AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175…

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.

Detox Transforms D-0979-2015

Class I · High risk Terminated Jan 25, 2015

iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175…

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.

Detox Transforms D-0978-2015

Class I · High risk Terminated Jan 25, 2015

EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC…

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.

Detox Transforms D-0977-2015

Class I · High risk Terminated Jan 20, 2015

0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02

Reason Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.

Hospira Inc. NDC 0409-7983-02 D-0969-2015

Class I · High risk Terminated Jan 20, 2015

Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne…

Reason Non-Sterility: Product tested positive for bacterial contamination.

Pacifico National, Inc. dba AmEx Pharmacy D-0870-2016

Class I · High risk Terminated Jan 20, 2015

Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL…

Reason Non-Sterility: Product tested positive for bacterial contamination.

Pacifico National, Inc. dba AmEx Pharmacy D-0869-2016

Class I · High risk Terminated Jan 13, 2015

fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL…

Reason Subpotent Drug

Pharmedium Services, LLC D-724-2016

Class I · High risk Terminated Jan 13, 2015

fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL…

Reason Subpotent Drug

Pharmedium Services, LLC D-723-2016

Class I · High risk Terminated Jan 6, 2015

Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111…

Reason Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.

Wallcur Incorporated D-0434-2015

Class I · High risk Terminated Dec 19, 2014

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and…

Bethel Nutritional Consulting, Inc D-1207-2015

Class I · High risk Terminated Dec 17, 2014

Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL…

Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Central Admixture Pharmacy Services, Inc. D-470-2015