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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 February 13, 2019 Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes,… GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample US Pharmaceuticals Inc. Terminated
Class II February 13, 2019 Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg… Defective Container: Potential for broken glass in the neck area of the glass bottles. Mylan Pharmaceuticals Inc. Terminated
Class II February 13, 2019 Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a)… GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample US Pharmaceuticals Inc. Terminated
Class II February 13, 2019 Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed… GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample US Pharmaceuticals Inc. Terminated
Class II February 6, 2019 GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN… Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. H J Harkins Company Inc dba Pharma Pac Terminated
Class II February 6, 2019 Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods… Lack of Processing Controls. Duren Health Mart Pharmacy Terminated
Class II February 6, 2019 Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's… Lack of Processing Controls. Duren Health Mart Pharmacy Terminated
Class II February 6, 2019 Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart… Lack of Processing Controls. Duren Health Mart Pharmacy Terminated
Class II February 6, 2019 Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93)… Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was… Mylan Pharmaceuticals Inc. Terminated
Class II February 6, 2019 Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart… Lack of Processing Controls. Duren Health Mart Pharmacy Terminated
Class II February 6, 2019 Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health… Lack of Processing Controls. Duren Health Mart Pharmacy Terminated
Class II February 6, 2019 Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only,… Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. Akorn, Inc. Terminated
Class II February 6, 2019 Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart… Lack of Processing Controls. Duren Health Mart Pharmacy Terminated
Class II February 6, 2019 BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by :… Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. Sun Pharmaceutical Industries, Inc. Terminated
Class II February 6, 2019 Irbesartan Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Prinston Pharmaceutical Inc Completed
Class II February 6, 2019 Cephalexin Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin… CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that… Lupin Pharmaceuticals Inc. Terminated
Class II February 6, 2019 Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Prinston Pharmaceutical Inc Completed
Class II February 6, 2019 Irbesartan and Hydrochlorothiazide Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Prinston Pharmaceutical Inc Completed
Class II February 6, 2019 Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by:… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Prinston Pharmaceutical Inc Completed
Class II February 6, 2019 Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by:… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Prinston Pharmaceutical Inc Completed
Class II January 30, 2019 Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2… Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the… Bound Tree Medical, LLC Terminated
Class II January 30, 2019 fluocinolone acetonide Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured… Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification… LUPIN SOMERSET Terminated
Class II January 30, 2019 Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC… Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the… Bound Tree Medical, LLC Terminated
Class II January 30, 2019 HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride… Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather… Advanced Pharma Inc. Terminated
Class III January 30, 2019 Loperamide Hydrochloride LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed… Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets.… Sun Pharmaceutical Industries, Inc. Terminated
Class II January 30, 2019 curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe… Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the… Bound Tree Medical, LLC Terminated
Class II January 30, 2019 Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured… Presence of Foreign Substance: Product complaint of black speckles observed on tablets. Dr. Reddy's Laboratories, Inc. Terminated
Class II January 30, 2019 curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe… Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the… Bound Tree Medical, LLC Terminated
Class I January 30, 2019 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together… Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil Happy Together, Inc. Terminated
Class III January 23, 2019 Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1… Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the… Bound Tree Medical, LLC Terminated
Class II January 23, 2019 Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a)… Failed dissolution specifications Teva Pharmaceuticals USA Terminated
Class II January 23, 2019 curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe… Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December… Bound Tree Medical, LLC Terminated
Class II January 23, 2019 Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured… CGMP Deviation; manufacturing batch record could not be located Lupin Pharmaceuticals Inc. Terminated
Class II January 23, 2019 EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count… CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Syntho Pharmaceuticals, Inc. Terminated
Class II January 23, 2019 EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count… CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Syntho Pharmaceuticals, Inc. Terminated
Class II January 23, 2019 Valsartan Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Amlodipine and Valsartan Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Amlodipine and Valsartan Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Amlodipine and Valsartan Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only,… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class II January 23, 2019 Amlodipine and Valsartan Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… Aurobindo Pharma USA Inc. Ongoing
Class I January 16, 2019 VECURONIUM BROMIDE Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized,… Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. Sun Pharmaceutical Industries, Inc. Terminated
Class I January 16, 2019 Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC… Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate… Lupin Pharmaceuticals Inc. Terminated
Class I January 16, 2019 Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01)… Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate… Lupin Pharmaceuticals Inc. Terminated
Class II January 16, 2019 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD… Subpotent PharMEDium Services, LLC. Terminated
Class II January 16, 2019 Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by:… Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle Heritage Pharmaceuticals, Inc. Terminated
Class I January 16, 2019 Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01)… Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate… Lupin Pharmaceuticals Inc. Terminated
Class I January 16, 2019 Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC… Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate… Lupin Pharmaceuticals Inc. Terminated
Class II January 16, 2019 Cefdinir Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20),… CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. Lupin Pharmaceuticals Inc. Terminated
Class II January 16, 2019 ESTRADIOL VAGINAL INSERTS Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC… Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator Glenmark Pharmaceuticals Inc., USA Terminated
Class II January 16, 2019 Cefdinir Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20),… CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. Lupin Pharmaceuticals Inc. Terminated
Class II January 16, 2019 OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator… GMP Deviations: A silicone particulate was noted in Ozurdex. Allergan, PLC. Completed
Class I January 16, 2019 VECURONIUM BROMIDE Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized,… Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. Sun Pharmaceutical Industries, Inc. Terminated
Class II January 16, 2019 DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL… Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. Baxter Healthcare Corporation Terminated
Class II January 9, 2019 Glutathione liquid, 200mg/ml, Rx Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Testosteron Cypionate liquid 200mg/ml, RX, glass vial Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Cyclosporin liquid 0.2%, Rx, plastic dropper bottle Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Methocarbamol liquid 100mg/ml, RX, glass vial Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Lidocaine gel 2%, RX, plastic dropper Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Cyclosporin liquid 1%, Rx, plastic dropper bottle Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Nitrofurantoin Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by:… Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. LUPIN SOMERSET Terminated
Class II January 9, 2019 Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable… Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Lidocaine gel 1%, RX, plastic dropper Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 HCG liquid, 1000u/ml, RX, glass vial, various Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Glutathione liquid, 100mg/ml Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Epinephrine liquid 1:1000, RX, glass vial Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Cyclosporin liquid 0.05%, Rx, plastic dropper bottle Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Vitamin B12 liquid 1000mcg/ml, RX, glass vial Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class II January 9, 2019 Cyclosporin liquid 0.5%, Rx, plastic dropper bottle Lack of sterility assurance. Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Terminated
Class I January 2, 2019 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1… Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the… Advanced Pharma Inc. Terminated
Class III January 2, 2019 Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason… Failed Dissolution Specifications Amerigen Pharmaceuticals Inc. Terminated
Class III January 2, 2019 Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count… Failed Dissolution Specifications Amerigen Pharmaceuticals Inc. Terminated
Class II December 26, 2018 infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25… Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Tris Pharma Inc. Terminated
Class III December 26, 2018 Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone… Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. CBI Laboratories, Inc. Terminated
Class II December 26, 2018 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25… Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Tris Pharma Inc. Terminated
Class II December 26, 2018 Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium… Sub-potent Pharmedium Services, LLC Terminated
Class I December 26, 2018 Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML… Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver Results RNA, LLC Terminated
Class II December 26, 2018 Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium… Sub-potent Pharmedium Services, LLC Terminated
Class II December 26, 2018 Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen… Superpotent Drug: contains higher levels of Iron than labeled. Gordon Laboratories Terminated
Class II December 26, 2018 Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West,… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Pharm D Solutions, LLC Terminated
Class II December 26, 2018 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25… Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Tris Pharma Inc. Terminated
Class III December 26, 2018 Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5… Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. CBI Laboratories, Inc. Terminated
Class II December 26, 2018 LEVOXYL Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx… Superpotent Drug. Pfizer Inc. Terminated
Class I December 26, 2018 Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem… Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer… Asclemed USA Inc. dba Enovachem Terminated
Class I December 26, 2018 Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem… Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer… Asclemed USA Inc. dba Enovachem Terminated
Class II December 26, 2018 Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by:… Failed Dissolution Specifications. Cipla Limited Terminated
Class II December 26, 2018 Oxybutynin Chloride Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech,… Labeling: Wrong bar code KVK-Tech, Inc. Terminated
Class II December 26, 2018 Estradiol Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC… Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg… Epic Pharma, LLC Terminated
Class III December 26, 2018 NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50… Failed Impurities/Degradation Specifications:Out of specification for impurities. VistaPharm, Inc. Terminated
Class III December 26, 2018 Aprepitant Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in… Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack. Glenmark Pharmaceuticals Inc., USA Terminated
Class III December 26, 2018 Absorica LD Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx… Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product… Sun Pharmaceutical Industries, Inc. Terminated
Class II December 26, 2018 OMNIPAQUE Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL… Defective Container: vial defect was identified that could potentially impact the container closure and result in a… GE Healthcare Inc. Life Sciences Terminated
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for:… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen… CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. Westminster Pharmaceuticals Llc Terminated
Class II December 19, 2018 Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen… CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. Westminster Pharmaceuticals Llc Terminated
Class II December 19, 2018 Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen… CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. Westminster Pharmaceuticals Llc Terminated
Class II December 19, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded… cGMP violations noted during the firm's most recent inspection. CAO Group, Inc. Terminated
Class II December 19, 2018 Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) &… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc… cGMP violations noted during the firm's most recent inspection. CAO Group, Inc. Terminated
Class II December 19, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) &… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) &… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC:… CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. LGM Pharma LLC Terminated
Class II December 19, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO… cGMP violations noted during the firm's most recent inspection. CAO Group, Inc. Terminated
Class III December 19, 2018 Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx… Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride QuVa Pharma, Inc. Terminated
Class II December 19, 2018 Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) &… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Teva Pharmaceuticals USA Ongoing
Class II December 19, 2018 BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged… cGMP violations noted during the firm's most recent inspection. CAO Group, Inc. Terminated
Class II December 19, 2018 Clopidogrel bisulfate Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only,… Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for… Dr. Reddy's Laboratories, Inc. Terminated
Class II December 19, 2018 Valsartan Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for:… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for:… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India,… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India,… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Mylan Laboratories Limited, (Nashik FDF) Ongoing
Class II December 19, 2018 Amlodipine and Valsartan Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Mylan Pharmaceuticals Inc. Ongoing
Class III December 12, 2018 Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle,… Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a… Aurobindo Pharma USA Inc. Terminated
Class I December 12, 2018 Sodium Chloride SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray,… Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product… Fresenius Kabi USA, LLC Terminated
Class I December 12, 2018 Sodium Chloride SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray,… Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product… Fresenius Kabi USA, LLC Terminated
Class II December 5, 2018 Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill… Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product AVKARE Inc. Terminated
Class II December 5, 2018 INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only,… Failed Stability Specification: out of specification for iron content. ALLERGAN Terminated
Class II December 5, 2018 Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to… Sandoz, Inc Ongoing
Class III December 5, 2018 Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget… Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities Akorn, Inc. Terminated
Class III December 5, 2018 Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles,… Cross contamination with other products: Product is being recalled due to the potential presence of unrelated… RemedyRepack Inc. Terminated
Class II December 5, 2018 Quetiapine Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem… Presence of Foreign Substance; metal shard found in tablet Ascend Laboratories LLC Terminated
Class II November 28, 2018 Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC,… Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Ecolab Inc Terminated
Class II November 28, 2018 GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b)… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Sciegen Pharmaceuticals Inc Terminated
Class II November 28, 2018 Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b)… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Sciegen Pharmaceuticals Inc Terminated
Class II November 28, 2018 IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. Golden State Medical Supply Inc. Terminated
Class II November 28, 2018 Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC,… Presence of foreign substance: Product found to contain metal particles. L. Perrigo Company Terminated
Class II November 28, 2018 Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b)… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Sciegen Pharmaceuticals Inc Terminated
Class II November 28, 2018 IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. Golden State Medical Supply Inc. Terminated
Class II November 28, 2018 IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. Golden State Medical Supply Inc. Terminated
Class III November 28, 2018 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose… Cross contamination with other products: This sub-recall is being initiated in support of the recall by the… AMERICAN HEALTH PACKAGING Terminated
Class II November 28, 2018 GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Sciegen Pharmaceuticals Inc Terminated
Class II November 28, 2018 GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Sciegen Pharmaceuticals Inc Terminated
Class II November 28, 2018 Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Sciegen Pharmaceuticals Inc Terminated
Class II November 28, 2018 Clopidogrel bisulfate Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only,… Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability… Dr. Reddy's Laboratories, Inc. Terminated
Class II November 28, 2018 Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL),… Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Ecolab Inc Terminated
Class II November 21, 2018 Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by:… Cross Contamination with Other Products Sandoz Inc Terminated
Class II November 21, 2018 children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free,… Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class III November 21, 2018 Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle,… Labeling Not Elsewhere Classified: Misbranding. Right Value Drug Stores, Inc. Terminated
Class III November 21, 2018 Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill… Labeling Not Elsewhere Classified: Misbranding. Right Value Drug Stores, Inc. Terminated
Class II November 21, 2018 Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz… Cross Contamination with Other Products Sandoz Inc Terminated
Class III November 21, 2018 Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed… Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability… Breckenridge Pharmaceutical, Inc. Terminated
Class II November 21, 2018 Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by:… Cross Contamination with Other Products Sandoz Inc Terminated
Class III November 21, 2018 Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill… Labeling Not Elsewhere Classified: Misbranding. Right Value Drug Stores, Inc. Terminated
Class III November 21, 2018 Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle,… Labeling Not Elsewhere Classified: Misbranding. Right Value Drug Stores, Inc. Terminated
Class II November 21, 2018 Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum… Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class III November 21, 2018 Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences… Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. RemedyRepack Inc. Terminated
Class II November 21, 2018 Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No… Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine Zero Xtreme USA Terminated
Class II November 21, 2018 Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx… Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine… Teva Pharmaceuticals USA Terminated
Class I November 21, 2018 puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972… Non-Sterility: Product manufactured under non-sterile production conditions. Kadesh International Terminated
Class III November 21, 2018 Amitiza AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo… Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample… Takeda Development Center Americas, Inc. Terminated
Class I November 21, 2018 Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards,… Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA… Epic Products, LLC Terminated
Class III November 21, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx… Cross Contamination with Other Products Sandoz Inc Terminated
Class II November 21, 2018 children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE,… Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II November 21, 2018 isosorbide dinitrate Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by:… Cross Contamination with Other Products Sandoz Inc Terminated
Class III November 21, 2018 ERBITUX ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx… Labeling: Missing label; potential for missing primary container label on the vial. Eli Lilly & Co Terminated
Class III November 21, 2018 Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a)… Cross Contamination with Other Products Sandoz Inc Terminated
Class I November 14, 2018 Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver… Microbial Contamination of Non-Sterile Products Silver Star Brands Terminated
Class II November 14, 2018 Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.)… CGMP Deviations: Product was released to market prior to microbiological testing. S.C. Johnson Professional Terminated
Class II November 14, 2018 Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by:… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Silver Star Brands Terminated
Class II November 14, 2018 Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75… Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for… Janssen Pharmaceuticals, Inc. Terminated
Class II November 14, 2018 Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class I November 14, 2018 Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver… Microbial Contamination of Non-Sterile Products Silver Star Brands Terminated
Class II November 14, 2018 Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC:… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class I November 14, 2018 Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver… Microbial Contamination of Non-Sterile Products Silver Star Brands Terminated
Class II November 14, 2018 Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen… Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for… Janssen Pharmaceuticals, Inc. Terminated
Class II November 14, 2018 Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Silver Star Brands Terminated
Class II November 14, 2018 Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous… Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month… Tailor Made Compounding Terminated
Class II November 14, 2018 Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class I November 14, 2018 Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by:… Microbial Contamination of Non-Sterile Product Silver Star Brands Terminated
Class II November 14, 2018 BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject… Lack of Assurance of Sterility Avella of Deer Valley, Inc. Store 38 Terminated
Class II November 14, 2018 Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count… Lack of Assurance of Sterility Qualgen, LLC Terminated
Class II November 14, 2018 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC… Lack of Assurance of Sterility; bags have the potential to leak ICU Medical Inc Terminated
Class II November 14, 2018 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC… Lack of Assurance of Sterility; bags have the potential to leak ICU Medical Inc Terminated
Class II November 14, 2018 SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC… Microbial Contamination of Non-Sterile Product Medline Industries Inc Terminated
Class III November 14, 2018 Metoprolol Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use… Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. Baxter Healthcare Corporation Terminated
Class III November 14, 2018 Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg,… Container packaging defect. Orexigen Therapeutics, Inc. Terminated
Class II November 14, 2018 deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.)… CGMP Deviations: Product was released to market prior to microbiological testing. S.C. Johnson Professional Terminated
Class II November 7, 2018 Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1704-01 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella… Lack of assurance of sterility Avella of Deer Valley, Inc. Store 38 Terminated
Class II November 7, 2018 Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of… Lack of assurance of sterility Avella of Deer Valley, Inc. Store 38 Terminated
Class II November 7, 2018 TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas ---… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by:… Failed Dissolution Specifications: OOS resultsduring routine stability testing Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class II November 7, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella… Lack of assurance of sterility Avella of Deer Valley, Inc. Store 38 Terminated
Class II November 7, 2018 Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated