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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 II July 10, 2013 Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 SODIUM CHLORIDE Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad… Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential… Baxter Healthcare Corp. Terminated
Class II July 10, 2013 Metronidazole Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter,… Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential… Baxter Healthcare Corp. Terminated
Class II July 10, 2013 HEPARIN SODIUM IN SODIUM CHLORIDE Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP… Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential… Baxter Healthcare Corp. Terminated
Class II July 10, 2013 Sodium Chloride 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC… Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential… Baxter Healthcare Corp. Terminated
Class II July 10, 2013 Dextrose 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL… Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential… Baxter Healthcare Corp. Terminated
Class II July 3, 2013 Sodium Chloride 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed… Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in… Baxter Healthcare Corp. Terminated
Class III July 3, 2013 Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4… Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… Hill Dermaceuticals, Inc. Terminated
Class II July 3, 2013 70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045,… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5%… Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed… Indelicare LLC Terminated
Class II July 3, 2013 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira,… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively… Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as… Kareway Product Inc Terminated
Class II July 3, 2013 INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No… Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed… Indelicare LLC Terminated
Class II July 3, 2013 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class II July 3, 2013 SODIUM CHLORIDE 0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL… Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Hospira Inc. Terminated
Class III June 26, 2013 Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for:… Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength. Mission Pharmacal Co Terminated
Class III June 26, 2013 Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg,… Failed Stability Specifications: Unable to meet shelf life expiry. Faria Limited LLC dba Sheffield Pharmaceuticals Terminated
Class II June 26, 2013 VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10… CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed… Sagent Pharmaceuticals Inc Terminated
Class II June 26, 2013 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx… Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port… Hospira Inc. Terminated
Class III June 26, 2013 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only,… Subpotent; 24 month stability test station Hi-Tech Pharmacal Co., Inc. Terminated
Class II June 26, 2013 Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister… Failed Dissolution Specification; during stability testing Teva Pharmaceuticals USA, Inc. Terminated
Class III June 26, 2013 Norpace Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a)… Failed Dissolution Specification Pfizer Inc Terminated
Class II June 26, 2013 Cleocin Phosphate Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage… Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent… Pharmacia & Upjohn LLC Terminated
Class II June 19, 2013 Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use… Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a… Sandoz Incorporated Terminated
Class III June 19, 2013 Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in… Failed Impurities/Degradation Specifications Actavis Terminated
Class I June 19, 2013 MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count… Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the… OLAAX International Terminated
Class I June 19, 2013 Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY… Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) Advance Pharmaceutical Inc Terminated
Class III June 19, 2013 Amoxicillin Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73… Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner… Teva Pharmaceuticals USA, Inc. Terminated
Class II June 12, 2013 CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC… Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications. Physicians Total Care, Inc. Terminated
Class III June 12, 2013 Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be… Novartis Consumer Health Terminated
Class II June 12, 2013 Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions Pentec Health Terminated
Class II June 12, 2013 NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by:… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for:… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class III June 12, 2013 Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA… CGMP Deviation; cotton coil is missing in some packaged bottles Teva Pharmaceuticals USA, Inc. Terminated
Class II June 12, 2013 Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class III June 12, 2013 Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146,… Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and… Physicians Total Care, Inc. Terminated
Class II June 12, 2013 Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz.… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class III June 12, 2013 Target Up & Up, athlete's foot cream, full prescription strength, terbinafine… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be… Novartis Consumer Health Terminated
Class II June 12, 2013 Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for:… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a)… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz.… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc.… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for:… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class III June 12, 2013 Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a)… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be… Novartis Consumer Health Terminated
Class II June 12, 2013 AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class III June 12, 2013 Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be… Novartis Consumer Health Terminated
Class II June 12, 2013 ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions Pentec Health Terminated
Class II June 12, 2013 Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only,… cGMP Deviation Petnet Solution Inc Terminated
Class II June 12, 2013 CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for:… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health Terminated
Class II June 12, 2013 Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC,… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc. Terminated
Class II June 12, 2013 B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine),… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St.… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class II June 12, 2013 MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC. Terminated
Class III June 12, 2013 Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be… Novartis Consumer Health Terminated
Class II June 12, 2013 DOBUTAMINE IN DEXTROSE DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only,… Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Hospira Inc. Terminated
Class II June 12, 2013 DIAZEPAM Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA,… Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc. Terminated
Class III June 12, 2013 Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals,… Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 Legacy Pharmaceutical Packaging LLC Terminated
Class III June 5, 2013 Lisinopril Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for:… Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label Aurobindo Pharma USA Inc Terminated
Class II June 5, 2013 PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only,… Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly… Mylan Pharmaceuticals Inc. Terminated
Class II June 5, 2013 HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class III June 5, 2013 Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Physicians Total Care, Inc. Terminated
Class II June 5, 2013 Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Meperidine 100mg/ml MDV, 5ml 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Lidocaine 2% Inj MDV, 20 ml 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class III June 5, 2013 Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during… Teva Pharmaceuticals USA, Inc. Terminated
Class II June 5, 2013 HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class II June 5, 2013 Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. Terminated
Class III June 5, 2013 Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl… Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected… Teva Pharmaceuticals USA, Inc. Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class III May 29, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x… Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle.… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class III May 29, 2013 Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be… Novartis Consumer Health Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class III May 29, 2013 Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan… Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.… Aaron Industries Inc Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 LEVOXYL Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles… Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle,… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class II May 29, 2013 Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet… cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine… Lloyd Inc. of Iowa Terminated
Class I May 22, 2013 Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only,… Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection). Gilead Sciences, Inc. Terminated
Class II May 22, 2013 Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class I May 22, 2013 Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL… Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA… Evol Nutrition Terminated
Class II May 22, 2013 Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Methylprednisolone and Dexamethasone Injection, all strengths and all presentations… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Human Chorionic Gonadotropin Injection, all strengths and all presentations including a)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only,… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class I May 22, 2013 CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC… Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… Performance Plus Marketing, Inc. Terminated
Class II May 22, 2013 Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Pyridoxine Hydrochloride Injection, all strengths and all presentations including… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Hydrochloric Acid Injection, all strengths and all presentations including a)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 B-Complex Injection, all strengths and all presentations including a) B-Complex Injection… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class II May 22, 2013 Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated
Class I May 22, 2013 libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10… Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA… Performance Plus Marketing, Inc. Terminated
Class II May 22, 2013 Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding… FVS Holdings, Inc. dba. Green Valley Drugs Terminated