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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class I July 13, 2016 XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class II July 13, 2016 MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx… Subpotent Drug Cantrell Drug Company Terminated
Class II July 13, 2016 All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class I July 13, 2016 Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC… Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class II July 13, 2016 Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612.… Failed Content Uniformity Specifications. Allergan Sales, LLC Terminated
Class II July 13, 2016 All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers. Vital Care Compounder, LLC Terminated
Class II July 13, 2016 All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class I July 13, 2016 fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only,… Subpotent Drug Cantrell Drug Company Terminated
Class II July 13, 2016 All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Products, Rx… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class I July 13, 2016 SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class I July 13, 2016 PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in… Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are… QuVa Pharma, Inc. Terminated
Class I July 13, 2016 La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health 37 N… Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class II July 13, 2016 All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only,… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class I July 13, 2016 XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class II July 13, 2016 All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class I July 13, 2016 SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd.… Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class I July 13, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL… Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. Hospira Inc. Ongoing
Class II July 13, 2016 All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class III July 13, 2016 Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber… Subpotency: product assayed and found OOS for cyproheptadine Lyne Laboratories, Inc. Terminated
Class I July 13, 2016 Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave… Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Bee Extremely Amazed LLC Terminated
Class II July 13, 2016 All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class II July 13, 2016 All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… Lack of Processing Controls Reliable Rexall-A Compounding Pharmacy Terminated
Class I July 13, 2016 fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only,… Subpotent Drug Cantrell Drug Company Terminated
Class III July 13, 2016 Sirolimus Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's… Failed impurities/degradation: out of specification result for impurity secorapamycin. Dr. Reddy's Laboratories, Inc. Terminated
Class II July 13, 2016 Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b)… Failed Content Uniformity Specifications. Allergan Sales, LLC Terminated
Class III July 6, 2016 SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only.… Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. Valeant Pharmaceuticals North America LLC Terminated
Class III July 6, 2016 Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by:… Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. Aidarex Pharmaceuticals LLC Terminated
Class III July 6, 2016 Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b)… Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results… Actavis Pharma Inc Terminated
Class III July 6, 2016 CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC,… Failed impurities/degradation specification: An out of specification results has been determined for an individual… Dr. Reddy's Laboratories, Inc. Terminated
Class II July 6, 2016 Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care… Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Vital Care Compounder Terminated
Class II July 6, 2016 Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder,… Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Vital Care Compounder Terminated
Class II July 6, 2016 aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic… CGMP Deviations The Aloe Source Terminated
Class II July 6, 2016 Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Vital Care Compounder Terminated
Class III July 6, 2016 Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH,… Discoloration: presence of scuffing marks on tablets. KVK-Tech, Inc. Terminated
Class III July 6, 2016 Lisinopril and Hydrochlorothiazide Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles… CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… Lupin Pharmaceuticals Inc. Terminated
Class II June 29, 2016 tabcin NOCHE; Capsules,12-count box, UPC 501008485033 CGMP Deviations Profarma Distributors LLC Terminated
Class III June 29, 2016 Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in… Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. Sandoz, Inc Terminated
Class III June 29, 2016 VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only,… Defective delivery system: Softgel capsules are leaking. Virtus Pharmaceuticals, Llc Terminated
Class III June 29, 2016 Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in… Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. Sandoz, Inc Terminated
Class III June 29, 2016 Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and… cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration Attix Pharmaceuticals Inc Terminated
Class II June 29, 2016 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 CGMP Deviations Profarma Distributors LLC Terminated
Class II June 29, 2016 VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 CGMP Deviations Profarma Distributors LLC Terminated
Class II June 29, 2016 VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 CGMP Deviations Profarma Distributors LLC Terminated
Class II June 29, 2016 tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 CGMP Deviations Profarma Distributors LLC Terminated
Class III June 29, 2016 Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only,… Chemical Contamination: Bottles may contain broken dessicants Virtus Pharmaceuticals, Llc Terminated
Class III June 29, 2016 Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by:… Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the… Prinston Pharmaceutical Inc Terminated
Class III June 22, 2016 Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only,… Failed Impurities/Degradation Specifications Valeant Pharmaceuticals North America LLC Terminated
Class II June 22, 2016 Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT… Failed Dissolution Specifications Nostrum Laboratories, Inc. Terminated
Class III June 22, 2016 Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count… Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an… Valeant Pharmaceuticals North America LLC Terminated
Class III June 22, 2016 Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc.,… Labeling: Incorrect or Missing Package Insert Sandoz Inc Terminated
Class III June 22, 2016 Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count… Failed Impurities/Degradation Specifications Valeant Pharmaceuticals North America LLC Terminated
Class III June 22, 2016 Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count… Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended… Par Pharmaceutical Terminated
Class II June 22, 2016 Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake… Presence of Particulate Matter: Cardboard Hospira Inc. Terminated
Class III June 22, 2016 Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme… Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial. Genzyme Corporation / Genzyme Biosurgery Terminated
Class III June 22, 2016 Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco… Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. Galderma Laboratories, L.P. Terminated
Class II June 22, 2016 SENSORCAINE Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx… Presence of Particulate Matter: Glass particulate found in sterile injectable product Fresenius Kabi USA, LLC Terminated
Class II June 15, 2016 SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas,… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Xcellerator (product not labeled) Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle… Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be… Reesna, Inc Terminated
Class II June 15, 2016 METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class I June 15, 2016 Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules.… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC,… Labeling; Product Contains Undeclared API (Oxybenzone) Bayer Health Care LLC Terminated
Class II June 15, 2016 QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class III June 15, 2016 CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by… CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API. Aidarex Pharmaceuticals LLC Terminated
Class II June 15, 2016 M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only,… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only,… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle… Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be… Reesna, Inc Terminated
Class II June 15, 2016 TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH… Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. Aidarex Pharmaceuticals LLC Terminated
Class II June 15, 2016 QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class I June 15, 2016 MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers.… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only,… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium… Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having… Pharmedium Services, LLC Terminated
Class I June 15, 2016 TruTrim (product not labeled) Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas,… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class II June 15, 2016 TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas,… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and… Well Care Compounding Pharmacy Terminated
Class I June 15, 2016 Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers.… Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. Novacare, LLC Terminated
Class II June 15, 2016 Norditropin Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx… Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called… Novo Nordisk Inc Terminated
Class I June 15, 2016 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only,… Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of… Baxter Healthcare Corp. Terminated
Class I June 15, 2016 Dextrose Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package,… Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of… Baxter Healthcare Corp. Terminated
Class II June 8, 2016 TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for… Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033 Invisiblu International LLC Ongoing
Class II June 8, 2016 Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY,… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY,… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class III June 8, 2016 Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931;… CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. Lupin Pharmaceuticals Inc. Terminated
Class III June 8, 2016 Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per… CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… Lupin Pharmaceuticals Inc. Terminated
Class II June 8, 2016 Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class III June 8, 2016 Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per… CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… Lupin Pharmaceuticals Inc. Terminated
Class II June 8, 2016 Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class III June 8, 2016 Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in… CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… Lupin Pharmaceuticals Inc. Terminated
Class II June 8, 2016 Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health… Lack of Sterility Assurance. Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class III June 8, 2016 Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in… CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… Lupin Pharmaceuticals Inc. Terminated
Class II June 8, 2016 Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health… Lack of Sterility Assurance Baptist Health Medical Towers Pharmacy and Infusion Services Terminated
Class II June 8, 2016 Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd.… Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability Akorn, Inc. Terminated
Class III June 8, 2016 ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample… Subpotent Drug Taro Pharmaceuticals U.S.A., Inc. Terminated
Class I June 1, 2016 Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle,… Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and… Centro Naturista Terminated
Class I June 1, 2016 Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle,… Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and… Centro Naturista Terminated
Class I June 1, 2016 Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle,… Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. Lucy's Weight Loss (dba. Waisted With Lucy) Terminated
Class I June 1, 2016 Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total,… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class II June 1, 2016 Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx… Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown… Akorn, Inc. Terminated
Class I June 1, 2016 Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle,… Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. Lucy's Weight Loss (dba. Waisted With Lucy) Terminated
Class I June 1, 2016 Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count… Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. Lucy's Weight Loss (dba. Waisted With Lucy) Terminated
Class II June 1, 2016 Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g… Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no… Lymol Medical Terminated
Class I June 1, 2016 Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total,… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class II June 1, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx… Failed Impuities/Degradation Specifications Fresenius Kabi USA, LLC Terminated
Class I June 1, 2016 Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC,… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by:… Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. Master Herbs, Inc./Li Terminated
Class I June 1, 2016 Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class II June 1, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx… Failed Impuities/Degradation Specifications Fresenius Kabi USA, LLC Terminated
Class II June 1, 2016 PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET… Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown… Akorn, Inc. Terminated
Class I June 1, 2016 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx… Presence of Particulate Matter: particulate matter identified as an insect in one vial. Hospira Inc. Ongoing
Class I June 1, 2016 Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class II June 1, 2016 Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged… Lack of Assurance of Sterility: Due to potential for leaking bags. Teva North America Terminated
Class I June 1, 2016 Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in… Presence of Particulate Matter: particulate matter identified as glass in one vial. Teva Pharmaceuticals USA Terminated
Class I June 1, 2016 Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic… Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. Lucy's Weight Loss (dba. Waisted With Lucy) Terminated
Class I June 1, 2016 Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy,… Non-Sterility: Product tested positive for bacterial contamination. Pacifico National, Inc. dba AmEx Pharmacy Terminated
Class I June 1, 2016 Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count… Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. Lucy's Weight Loss (dba. Waisted With Lucy) Terminated
Class I June 1, 2016 Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total),… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC,… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class II June 1, 2016 ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET… Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown… Akorn, Inc. Terminated
Class I June 1, 2016 LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos… Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted… Lipo Escultura Corp. Terminated
Class I June 1, 2016 Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total,… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy,… Non-Sterility: Product tested positive for bacterial contamination. Pacifico National, Inc. dba AmEx Pharmacy Terminated
Class I June 1, 2016 Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1… Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj. Pharmakon Pharmaceuticals Terminated
Class I June 1, 2016 Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240… Marketed Without An Approved NDA/ANDA R Thomas Marketing, LLC Terminated
Class I June 1, 2016 SUPER HERBS 350 mg, 30 capsules per bottle. Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite… Super Herbs Terminated
Class I June 1, 2016 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors… Defective Delivery System; potential to have inaccurate dosage delivery Sanofi-Aventis U.S. LLC Terminated
Class I June 1, 2016 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors… Defective Delivery System; potential to have inaccurate dosage delivery Sanofi-Aventis U.S. LLC Terminated
Class I June 1, 2016 Metronidazole Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose… Presence of Particulate Matter: identified as a cloth fiber. Baxter Healthcare Corp. Terminated
Class II June 1, 2016 Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by… Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. Pfizer Inc. Terminated
Class I June 1, 2016 Sodium Chloride 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose… Presence of Particulate Matter: identified as cardboard. Baxter Healthcare Corp. Terminated
Class II June 1, 2016 Sodium Chloride 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose… Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility. Baxter Healthcare Corp. Terminated