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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 August 27, 2014 fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For… Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were… Healix Infusion Therapy, Inc. Terminated
Class I August 27, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy… Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination. Pharmacy Creations Terminated
Class II August 27, 2014 Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183,… Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new… Doctor's Best, Inc. Terminated
Class II August 27, 2014 Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle… Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time… Wockhardt Usa Inc. Terminated
Class II August 27, 2014 Propranolol PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP… CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies… Fresenius Kabi USA, LLC Terminated
Class I August 27, 2014 DOBUTAMINE DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only,… Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass… Hospira Inc. Terminated
Class II August 27, 2014 ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx… Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a… Baxter Healthcare Corp Terminated
Class I August 27, 2014 propofol Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx… Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample… Hospira Inc. Terminated
Class I August 20, 2014 Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts… Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165,… Bacai Inc. Dba Ky Duyen House Terminated
Class I August 20, 2014 Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for &… Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. Sung Soo Kim Terminated
Class II August 20, 2014 Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured… Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due… Teva Pharmaceuticals USA Terminated
Class III August 20, 2014 Depo-Medrol Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL… Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The… Pfizer Inc. Terminated
Class III August 20, 2014 E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by… Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after… Bracco Diagnostic Inc Terminated
Class II August 13, 2014 G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use,… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc.,… Presence of Foreign Substance; tablets may contain stainless steel metal particulates Mckesson Packaging Services Terminated
Class II August 13, 2014 MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and… CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical… Caraco Pharmaceutical Laboratories, Ltd. Terminated
Class II August 13, 2014 Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml,… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use,… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class III August 13, 2014 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only,… Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. Wockhardt Usa Inc. Terminated
Class II August 13, 2014 Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC,… Microbial Contamination of Non-Sterile Product HLI dba Humphreyline Inc Terminated
Class II August 13, 2014 L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial,… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class III August 13, 2014 Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured… Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to… Novartis Pharmaceuticals Corp. Terminated
Class II August 13, 2014 Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial,… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and… CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical… Caraco Pharmaceutical Laboratories, Ltd. Terminated
Class II August 13, 2014 Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made… CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. SST Corporation Terminated
Class II August 13, 2014 Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm… Medical Supply Liquidators Llc Terminated
Class II August 13, 2014 RISPERDAL CONSTA Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen… Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability… Janssen Pharmaceuticals, Inc. Terminated
Class I August 13, 2014 Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only,… Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled… Alexion Pharmaceuticals, Inc. Terminated
Class II August 6, 2014 Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription… Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. Fagron, Inc Terminated
Class II August 6, 2014 Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription… Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. Fagron, Inc Terminated
Class III August 6, 2014 Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson… Failed Dissolution Specification; at the 12 month time interval. Mckesson Packaging Services Terminated
Class III August 6, 2014 OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only.… Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Boehringer Ingelheim Roxane Inc Terminated
Class II August 6, 2014 Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg,… Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results… Teva Pharmaceuticals USA Terminated
Class II August 6, 2014 Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription… Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. Fagron, Inc Terminated
Class II August 6, 2014 Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Terminated
Class II August 6, 2014 Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for:… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during… Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during… Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during… Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for:… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 Alprazolam Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ ---… Presence of Foreign Substance; tablets may contain stainless steel metal particulates Sandoz Incorporated Terminated
Class II August 6, 2014 Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development Terminated
Class III August 6, 2014 Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only,… Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. Pfizer Inc. Terminated
Class II August 6, 2014 Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for:… Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development Terminated
Class II August 6, 2014 losartan potassium and hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per… Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. Jubilant Cadista Pharmaceuticals Inc. Terminated
Class III July 30, 2014 Clonidine Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only,… Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg… X-Gen Pharmaceuticals Inc. Terminated
Class II July 30, 2014 Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street,… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class I July 30, 2014 Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine.… Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules Shamrock Medical Solutions Group LLC Terminated
Class II July 30, 2014 Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain… Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride… Shamrock Medical Solutions Group LLC Terminated
Class II July 30, 2014 Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala,… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala,… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class I July 30, 2014 Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine… Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL Shamrock Medical Solutions Group LLC Terminated
Class II July 30, 2014 Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate… Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg Shamrock Medical Solutions Group LLC Terminated
Class II July 30, 2014 Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class III July 30, 2014 DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate… Stability Data Does Not Support Expiry Estee Lauder Inc Terminated
Class II July 30, 2014 Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street,… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class II July 30, 2014 Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Franck's Lab Inc dba Trinity Care Solutions Ongoing
Class I July 30, 2014 metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release… Labeling: Label Mix up; product labeled did not indicated Extended Release Shamrock Medical Solutions Group LLC Terminated
Class III July 30, 2014 Orphenadrine Citrate Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC… Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. Sandoz Inc Terminated
Class II July 30, 2014 Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged… Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of… Shamrock Medical Solutions Group LLC Terminated
Class II July 23, 2014 Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco… Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number Axcentria Pharmaceuticals, LLC Terminated
Class III July 23, 2014 POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg,… Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately… Poly Pharmaceuticals, Inc Terminated
Class III July 23, 2014 Apri Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic… Failed Impurities/Degradation Specifications: out of specification impurity test results. Teva Pharmaceuticals USA Terminated
Class III July 23, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10)… Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class III July 23, 2014 Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use… Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Fougera Pharmaceuticals Inc. Terminated
Class III July 23, 2014 Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg… Failed Impurities/Degradation Specifications: out of specification impurity test results. Teva Pharmaceuticals USA Terminated
Class III July 23, 2014 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use… Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Fougera Pharmaceuticals Inc. Terminated
Class III July 23, 2014 Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg;… Failed Impurities/Degradation Specifications: out of specification impurity test results. Teva Pharmaceuticals USA Terminated
Class III July 23, 2014 LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100… Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately… Poly Pharmaceuticals, Inc Terminated
Class III July 23, 2014 Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and… Failed Impurities/Degradation Specifications: out of specification impurity test results. Teva Pharmaceuticals USA Terminated
Class II July 23, 2014 ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. CareFusion 213, LLC Terminated
Class III July 23, 2014 VIRACEPT VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only,… Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The… Pfizer Inc. Terminated
Class II July 23, 2014 Fentanyl Citrate Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL… Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Hospira Inc. Terminated
Class II July 16, 2014 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium… Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample… Fresenius Kabi USA, LLC Terminated
Class II July 16, 2014 Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium… Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample… Fresenius Kabi USA, LLC Terminated
Class II July 16, 2014 Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL… Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems… United Therapeutics Corp. Terminated
Class II July 16, 2014 BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr)… Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25%… Healix Infusion Therapy, Inc. Terminated
Class II July 16, 2014 Calcitriol Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc.,… Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability… Boehringer Ingelheim Roxane Inc Terminated
Class II July 16, 2014 Fluvastatin Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva… Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin… Teva Pharmaceuticals USA Terminated
Class II July 16, 2014 Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100… Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. Hospira Inc. Terminated
Class III July 16, 2014 ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured… Discoloration; due to prolonged heat exposure. Ferring Pharmaceuticals Inc Terminated
Class II July 16, 2014 Labetalol Hydrochloride Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial,… Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution Hospira Inc. Terminated
Class II July 9, 2014 HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000… Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Terminated
Class II July 9, 2014 HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol… Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Terminated
Class II July 9, 2014 Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx,… Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Terminated
Class II July 9, 2014 Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC… Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point. West-Ward Pharmaceutical Corp. Terminated
Class II July 9, 2014 Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom… Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Terminated
Class II July 9, 2014 Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only.… Failed Dissolution Specifications: Drug failed stage III dissolution testing. Forest Pharmaceuticals Inc Terminated
Class II July 9, 2014 HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL… Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Terminated
Class II July 9, 2014 HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD… Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Terminated
Class II July 9, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count… Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications. Caraco Pharmaceutical Laboratories, Ltd. Terminated
Class II July 9, 2014 BREVIBLOC Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL… Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron… Baxter Healthcare Corp. Terminated
Class II July 2, 2014 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton,… Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty,… Bausch & Lomb, Inc. Terminated
Class II July 2, 2014 Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile… Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of… Caraco Pharmaceutical Laboratories, Ltd. Terminated
Class II July 2, 2014 Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube… Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty,… Bausch & Lomb, Inc. Terminated
Class II July 2, 2014 Dextroamphetamine Sulfate Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr… Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result… Teva Pharmaceuticals USA Terminated
Class II July 2, 2014 Pristiq Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only,… Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets… Pfizer Us Pharmaceutical Group Terminated
Class II June 25, 2014 Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg,… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g,… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class III June 25, 2014 Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60… Failed Stability Specification; out of specification result for particle size distribution during stability testing Novartis Pharmaceuticals Corp. Terminated
Class II June 25, 2014 Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister… Subpotent Drug. Actavis Inc Terminated
Class II June 25, 2014 Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles,… Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be… Thorne Research Inc Terminated
Class II June 25, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains:… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles,… Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be… Thorne Research Inc Terminated
Class II June 25, 2014 TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only,… Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of… Ferring Pharmaceuticals Inc Terminated
Class II June 25, 2014 Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg,… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride,… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg,… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class II June 25, 2014 Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg,… Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Terminated
Class I June 18, 2014 vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count… Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules Vitality Research Labs LLC Terminated
Class I June 18, 2014 Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine,… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles,… Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition Terminated
Class II June 18, 2014 Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose… Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain… Legacy Pharmaceutical Packaging Terminated
Class I June 18, 2014 Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles,… Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition Terminated
Class I June 18, 2014 Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC,… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only,… Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn… Greenstone Llc Terminated
Class I June 18, 2014 Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles,… Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition Terminated
Class I June 18, 2014 Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx… Superpotent Drug: Product contains twice the stated amount of midazolam. Pharmakon Pharmaceuticals Terminated
Class I June 18, 2014 Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles,… Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition Terminated
Class I June 18, 2014 Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles,… Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition Terminated
Class I June 18, 2014 Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC,… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs,… Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient:… MyNicNaxs, Inc. Terminated
Class I June 18, 2014 Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles,… Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition Terminated
Class I June 18, 2014 CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for:… Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. Cubist Pharmaceuticals, Inc. Terminated
Class II June 18, 2014 Metoprolol succinate Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle,… Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. Dr. Reddy's Laboratories, Inc. Terminated
Class II June 11, 2014 CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine… Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The… Carefusion 2200 Inc Terminated
Class II June 11, 2014 LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow… Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning Golden State Medical Supply Inc. Terminated
Class II June 11, 2014 CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine… Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The… Carefusion 2200 Inc Terminated
Class I June 11, 2014 Marcaine Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg)… Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles… Hospira Inc. Terminated
Class II June 11, 2014 Fluconazole GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when… Defective Container: Tamper evident ring failures discovered on some bottles. Pfizer Inc. Terminated
Class III June 4, 2014 PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and… Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Prestige Brands Holdings Terminated
Class III June 4, 2014 PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5… Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Prestige Brands Holdings Terminated
Class II June 4, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only.… Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. Wockhardt Usa Inc. Terminated
Class I June 4, 2014 Burn 7 Capsules, supplied in 30 capsules bottle Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement Deseo Rebajar Terminated
Class II June 4, 2014 ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed… Non-sterility: due to a failed sterility test Teva Pharmaceuticals USA Terminated
Class II June 4, 2014 Cefpodoxime Proxetil Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in… Presence of Foreign Substance: Presence of stainless steel particles. Sandoz, Inc Terminated
Class I May 28, 2014 Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc.,… Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of… Ben Venue Laboratories Inc Terminated
Class I May 28, 2014 Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle,… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and… Herbal Give Care Llc Terminated
Class I May 28, 2014 NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10,… Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient,… Tendex Terminated
Class I May 28, 2014 Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For:… Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class I May 28, 2014 ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena,… Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class I May 28, 2014 Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and… Herbal Give Care Llc Terminated
Class I May 28, 2014 BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3… Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class I May 28, 2014 Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and… Herbal Give Care Llc Terminated
Class II May 28, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva… Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during… Teva Pharmaceuticals USA Terminated
Class I May 28, 2014 Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and… Herbal Give Care Llc Terminated
Class I May 28, 2014 P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10,… Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient,… Tendex Terminated
Class I May 28, 2014 Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and… Herbal Give Care Llc Terminated
Class III May 28, 2014 Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by:… Labeling: Missing Label; The label on the immediate bottle is missing. Oasis Medical Inc Terminated
Class II May 28, 2014 QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered… Defective Delivery System; defective valve Teva Pharmaceuticals USA Terminated
Class II May 28, 2014 Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured… Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. Zydus Pharmaceuticals USA Inc Terminated
Class II May 28, 2014 Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps… Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is… Independent Nutrition Center, Inc. Terminated
Class I May 28, 2014 XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class II May 28, 2014 Liothyronine Sodium Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and… Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to… SigmaPharm Laboratories LLC Terminated
Class II May 28, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva… Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during… Teva Pharmaceuticals USA Terminated
Class I May 28, 2014 MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life… Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class I May 28, 2014 SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY. Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class I May 28, 2014 XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of… Schindele Enterprises dba Midwest Wholesale Terminated
Class I May 28, 2014 PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human… Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac,… HUMAN SCIENCE FOUNDATION Terminated
Class II May 28, 2014 phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for… Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical… Fresenius Medical Care Holdings, Inc. Terminated
Class II May 28, 2014 Bystolic Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan… Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results… Forest Pharmaceuticals Inc Terminated
Class I May 28, 2014 Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count… Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a… Pfizer Us Pharmaceutical Group Terminated
Class III May 21, 2014 PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl… Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Konsyl Pharmaceuticals Inc Terminated
Class II May 21, 2014 INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By:… CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA Terminated
Class II May 21, 2014 METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By:… CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA Terminated
Class II May 21, 2014 Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20… First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing… First Aid Only Inc Terminated
Class II May 21, 2014 GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle,… CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA Terminated
Class I May 21, 2014 REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva… Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. Pain Free By Nature Terminated
Class II May 21, 2014 INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count… CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA Terminated
Class II May 21, 2014 Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200… Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as… Flawless Beauty LLC Completed
Class II May 21, 2014 Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box,… Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be… Flawless Beauty LLC Completed
Class II May 21, 2014 Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL… Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as… Flawless Beauty LLC Completed
Class II May 21, 2014 Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box,… Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for… Flawless Beauty LLC Completed
Class II May 21, 2014 Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per… Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Flawless Beauty LLC Completed
Class II May 21, 2014 Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution,… Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used… Flawless Beauty LLC Completed
Class III May 14, 2014 Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc.,… Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36… Boehringer Ingelheim Roxane Inc Terminated
Class II May 14, 2014 Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray… Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti Terminated
Class II May 14, 2014 Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu… Defective container: Product distributed without inner seal on bottles. Blu Pharmaceuticals Inc Terminated
Class III May 14, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC… This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed… Merck & Co Inc Terminated
Class III May 14, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC… This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed… Merck & Co Inc Terminated
Class II May 14, 2014 Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray… Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti Terminated
Class II May 14, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only,… Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. Wockhardt Usa Inc. Terminated
Class II May 14, 2014 Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray… Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti Terminated
Class III May 14, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC… Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially… Merck & Co Inc Terminated
Class II May 14, 2014 Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu… Defective container: Product distributed without inner seal on bottles. Blu Pharmaceuticals Inc Terminated
Class III May 14, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC… This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed… Merck & Co Inc Terminated
Class II May 14, 2014 Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray… Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti Terminated
Class II May 14, 2014 Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle,… Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti Terminated
Class II May 14, 2014 Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle,… Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti Terminated
Class III May 14, 2014 Mercaptopurine Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc.,… Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36… Boehringer Ingelheim Roxane Inc Terminated