FDA Drug · 2016
FDA Drug recalls in 2016
RecallRadar indexes 1,254 FDA Drug recall notices published in 2016. By classification: 130 Class I, 963 Class II, 161 Class III.
- Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Hone…
FDA Drug · Class I · 2016-12-28 · Sperian Eye And Face Protection - Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II,…
FDA Drug · Class I · 2016-12-28 · Virtus Pharmaceuticals Opco Ii L - Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Am…
FDA Drug · Class II · 2016-12-28 · Inventia Healthcare Private - Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit…
FDA Drug · Class III · 2016-12-28 · Les Emballages Knowlton - Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 0…
FDA Drug · Class I · 2016-12-28 · Town And Country Compounding And Consultation Services - C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
FDA Drug · Class II · 2016-12-28 · Colonia Care Pharmacy - Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
FDA Drug · Class I · 2016-12-28 · Love My Tru Body - 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705…
FDA Drug · Class II · 2016-12-28 · Sage Products - AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactu…
FDA Drug · Class II · 2016-12-28 · Amgen - Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services
FDA Drug · Class II · 2016-12-28 · Meta Pharmacy Services - Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
FDA Drug · Class I · 2016-12-28 · Guardian Pharmacy Services - Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake…
FDA Drug · Class I · 2016-12-28 · Hospira A Pfizer - BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C
FDA Drug · Class I · 2016-12-28 · Making It A Lifestyle - BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (ND…
FDA Drug · Class III · 2016-12-28 · Zydus Pharmaceuticals Usa - C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
FDA Drug · Class II · 2016-12-28 · Colonia Care Pharmacy - GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Ba…
FDA Drug · Class I · 2016-12-28 · Novo Nordisk - Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson…
FDA Drug · Class I · 2016-12-28 · Impax Laboratories - 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C
FDA Drug · Class II · 2016-12-28 · Making It A Lifestyle - Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York…
FDA Drug · Class I · 2016-12-28 · Ultimate Body Tox - Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashv…
FDA Drug · Class I · 2016-12-28 · Virtus Pharmaceuticals Opco Ii L - COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into in…
FDA Drug · Class II · 2016-12-28 · Sage Products - COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into in…
FDA Drug · Class I · 2016-12-28 · Sage Products - Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deer…
FDA Drug · Class II · 2016-12-28 · Baxter Healthcare - Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), U…
FDA Drug · Class I · 2016-12-28 · Us Compounding - BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C
FDA Drug · Class I · 2016-12-28 · Making It A Lifestyle - Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC.,…
FDA Drug · Class I · 2016-12-28 · Virtus Pharmaceuticals Opco Ii L - Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell R…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Inj…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantre…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, A…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantre…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 732…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Dru…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Offic…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell R…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 218…
FDA Drug · Class III · 2016-12-21 · Jubilant Cadista Pharmaceuticals - Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrel…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Ro…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little R…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Ca…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Ro…
FDA Drug · Class II · 2016-12-21 · Cantrell Drug - Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 1…
FDA Drug · Class III · 2016-12-14 · Teva Pharmaceuticals Usa - Range Trauma Kit - Product Code 85-1274, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 T…
FDA Drug · Class II · 2016-12-14 · Fallon Wellness Pharmacy - 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured…
FDA Drug · Class III · 2016-12-14 · Hospira - Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmace…
FDA Drug · Class III · 2016-12-14 · West Ward Pharmaceuticals - Aid Backpack Kit - Product Code 85-0917, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - USCG Boat Response Kit - Product Code 80-0353, North American Rescue
FDA Drug · Class II · 2016-12-14 · North American Rescue - PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy…
FDA Drug · Class II · 2016-12-14 · Fallon Wellness Pharmacy - Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 1…
FDA Drug · Class III · 2016-12-14 · Teva Pharmaceuticals Usa - Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by…
FDA Drug · Class II · 2016-12-07 · Par Pharmaceutical - Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18)
FDA Drug · Class II · 2016-12-07 · Nationwide Laboratories - Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Meth…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
FDA Drug · Class II · 2016-12-07 · Cadila Pharmaceuticals - Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methyle…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10)
FDA Drug · Class II · 2016-12-07 · Nationwide Laboratories - UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene B…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New…
FDA Drug · Class II · 2016-12-07 · Nationwide Laboratories - Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New…
FDA Drug · Class II · 2016-12-07 · Nationwide Laboratories - Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distr…
FDA Drug · Class II · 2016-12-07 · Ascend Laboratories - Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Man…
FDA Drug · Class III · 2016-11-30 · Mylan Pharmaceuticals - KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx…
FDA Drug · Class III · 2016-11-30 · Sun Pharmaceutical Industries - Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093…
FDA Drug · Class II · 2016-11-30 · Hospira - Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Ak…
FDA Drug · Class II · 2016-11-30 · Akorn - Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwid…
FDA Drug · Class III · 2016-11-30 · Sandoz - Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp
FDA Drug · Class II · 2016-11-30 · West Ward Pharmaceuticals - LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals,…
FDA Drug · Class II · 2016-11-30 · Pfizer - Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 18…
FDA Drug · Class III · 2016-11-30 · West Ward Pharmaceuticals - Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039…
FDA Drug · Class II · 2016-11-30 · Vistapharm - AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01)
FDA Drug · Class III · 2016-11-30 · Amerisource Health Services - NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Eliza…
FDA Drug · Class III · 2016-11-30 · Actavis Elizabeth - BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd
FDA Drug · Class III · 2016-11-30 · Zydus Pharmaceuticals Usa - L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per…
FDA Drug · Class II · 2016-11-23 · Sandoz - FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-07…
FDA Drug · Class III · 2016-11-23 · Cutispharma - L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per ca…
FDA Drug · Class II · 2016-11-23 · Sandoz - Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-2…
FDA Drug · Class III · 2016-11-23 · Amerisource Health Services - Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Resear…
FDA Drug · Class III · 2016-11-23 · Gsk Consumer Healthcare - FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-0…
FDA Drug · Class III · 2016-11-23 · Cutispharma - Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network
FDA Drug · Class III · 2016-11-16 · Wells Pharmacy Network - Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
FDA Drug · Class III · 2016-11-16 · Wells Pharmacy Network - Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceut…
FDA Drug · Class III · 2016-11-16 · Mylan Institutional D B A Udl Laboratories - Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
FDA Drug · Class III · 2016-11-16 · Wells Pharmacy Network
Other years
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