FDA Drug · 2012
FDA Drug recalls in 2012
RecallRadar indexes 434 FDA Drug recall notices published in 2012. By classification: 19 Class I, 349 Class II, 66 Class III.
- Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Sol…
FDA Drug · Class II · 2012-10-03 · Dispensing Solutions - Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2012-10-03 · Mylan Pharmaceuticals - 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfiel…
FDA Drug · Class II · 2012-10-03 · Baxter Healthcare - Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02
FDA Drug · Class II · 2012-10-03 · Baxter Healthcare - 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
FDA Drug · Class II · 2012-10-03 · Baxter Healthcare - Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-92…
FDA Drug · Class II · 2012-10-03 · Abbott Laboratories - Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Bio…
FDA Drug · Class I · 2012-10-03 · Www Vitaminbestbuy Com - Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbest…
FDA Drug · Class I · 2012-10-03 · Www Vitaminbestbuy Com - NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, I…
FDA Drug · Class II · 2012-10-03 · Glenmark Generics Usa - Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30
FDA Drug · Class II · 2012-10-03 · Hospira - Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold…
FDA Drug · Class I · 2012-10-03 · Www Vitaminbestbuy Com - CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured…
FDA Drug · Class II · 2012-10-03 · Bracco Diagnostics - 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02
FDA Drug · Class II · 2012-10-03 · Baxter Healthcare - Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-455…
FDA Drug · Class II · 2012-10-03 · Abbott Laboratories - Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For In…
FDA Drug · Class III · 2012-10-03 · Mallinckrodt - Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr
FDA Drug · Class I · 2012-10-03 · Ben Venue Laboratories - Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in singl…
FDA Drug · Class II · 2012-10-03 · Actavis - Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-518…
FDA Drug · Class II · 2012-10-03 · Abbott Laboratories - 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02
FDA Drug · Class II · 2012-10-03 · Baxter Healthcare - ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 2604…
FDA Drug · Class II · 2012-09-26 · Carefusion 213 - Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
FDA Drug · Class III · 2012-09-26 · Apace Ky - Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent
FDA Drug · Class II · 2012-09-26 · Hospira - Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent
FDA Drug · Class II · 2012-09-26 · Hospira - Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sando…
FDA Drug · Class III · 2012-09-26 · Sandoz - ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter
FDA Drug · Class II · 2012-09-26 · Dukal - Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent
FDA Drug · Class II · 2012-09-26 · Hospira - Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sand…
FDA Drug · Class III · 2012-09-26 · Sandoz - Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent
FDA Drug · Class II · 2012-09-26 · Hospira - Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged sw…
FDA Drug · Class II · 2012-09-26 · Dukal - Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UP…
FDA Drug · Class II · 2012-09-12 · Medtech Products - Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apote…
FDA Drug · Class II · 2012-09-05 · Apotex - Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontar…
FDA Drug · Class II · 2012-09-05 · Apotex - Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Can…
FDA Drug · Class III · 2012-09-05 · Apotex - Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with…
FDA Drug · Class II · 2012-09-05 · Glaxosmithkline - Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Prin…
FDA Drug · Class III · 2012-09-05 · Bracco Diagnostics - Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550…
FDA Drug · Class II · 2012-09-05 · American Health Packaging - Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, R…
FDA Drug · Class II · 2012-09-05 · Bracco Diagnostics - Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc
FDA Drug · Class II · 2012-09-05 · Hospira - Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galde…
FDA Drug · Class III · 2012-09-05 · Galderma Laboratories L P - Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237…
FDA Drug · Class II · 2012-09-05 · Capco Custom Packaging - Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, C…
FDA Drug · Class III · 2012-09-05 · Natural Essentials - CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled…
FDA Drug · Class II · 2012-09-05 · Island Kinetics - METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
FDA Drug · Class III · 2012-09-05 · Vistapharm - Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-08-29 · Noven Pharmaceuticals - Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC…
FDA Drug · Class II · 2012-08-29 · Prometheus Laboratories - CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330…
FDA Drug · Class II · 2012-08-29 · Custom Medical Specialties - Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-08-29 · Noven Pharmaceuticals - Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC…
FDA Drug · Class II · 2012-08-29 · Vistapharm - Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-08-29 · Noven Pharmaceuticals - Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.…
FDA Drug · Class II · 2012-08-29 · Victus - V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561
FDA Drug · Class I · 2012-08-29 · The Menz Club - Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124…
FDA Drug · Class II · 2012-08-29 · Custom Medical Specialties - Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags
FDA Drug · Class III · 2012-08-29 · Morton Salt - CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialtie…
FDA Drug · Class II · 2012-08-29 · Custom Medical Specialties - PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML 2 ML 20 ML 20 MLS 24 ML 3 ML 30 ML 5 ML 6 ML 8 ML…
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 1…
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS 4 ML 40 ML 5 ML 6 ML 60 ML 80 ML 90 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - NADH-FFC 10 MG/CC INJECTABLE 10 ML (1 PRODUCT)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML…
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab - INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT
FDA Drug · Class II · 2012-08-22 · Franck S Lab D B A Franck S Compounding Lab
Other years
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