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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10 Impax Laboratories, Inc. Class II Terminated 20160427
Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4. Torrent Pharmaceuticals Limited Class III Terminated 20160427
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33. Amerisource Health Services Class III Terminated 20160420
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33. Amerisource Health Services Class III Terminated 20160420
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 Impax Laboratories, Inc. Class III Terminated 20160420
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 Impax Laboratories, Inc. Class III Terminated 20160420
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10 Fresenius Kabi USA, LLC Class II Terminated 20160420
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. Fresenius Kabi USA, LLC Class III Terminated 20160420
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134 Biocon Inc Class III Terminated 20160420
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11. Actavis Elizabeth LLC Class II Terminated 20160413
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11. Actavis Elizabeth LLC Class II Terminated 20160413
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11. Actavis Elizabeth LLC Class II Terminated 20160413
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11. Actavis Elizabeth LLC Class II Terminated 20160413
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 Jubilant Draximage Inc Class III Terminated 20160413
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. Apace KY LLC Class III Terminated 20160413
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30. Purdue Pharma L.P. Class III Terminated 20160413
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51 Bio-pharm, Inc. Class III Terminated 20160413
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. Meditech Laboratories, Inc Class II Terminated 20160413
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. Meditech Laboratories, Inc Class II Terminated 20160413
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. Meditech Laboratories, Inc Class II Terminated 20160413
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. Meditech Laboratories, Inc Class II Terminated 20160413
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. Meditech Laboratories, Inc Class II Terminated 20160413
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. . Meditech Laboratories, Inc Class II Terminated 20160413
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. Meditech Laboratories, Inc Class II Terminated 20160413
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305 Virtus Pharmaceuticals, Llc Class III Terminated 20160413
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18 Pfizer Inc Class III Terminated 20160406
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1 Genzyme Corporation Class III Terminated 20160406
Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60 Walter's Pharmacy Class II Terminated 20160406
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54 Walter's Pharmacy Class II Terminated 20160406
Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61 Walter's Pharmacy Class II Terminated 20160406
Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47 Walter's Pharmacy Class II Terminated 20160406
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33 Walter's Pharmacy Class II Terminated 20160406
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09 Walter's Pharmacy Class II Terminated 20160406
Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78 Walter's Pharmacy Class II Terminated 20160406
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35 Walter's Pharmacy Class II Terminated 20160406
Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92 Walter's Pharmacy Class II Terminated 20160406
Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706 Walter's Pharmacy Class II Terminated 20160406
Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99 Walter's Pharmacy Class II Terminated 20160406
Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47 Walter's Pharmacy Class II Terminated 20160406
Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04 Walter's Pharmacy Class II Terminated 20160406
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304. Safecor Health, LLC Class II Terminated 20160406
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52 Dr. Reddy's Laboratories, Inc. Class II Terminated 20160406
UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, Praxair Inc. Class III Terminated 20160406
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006. Praxair Inc. Class III Terminated 20160406
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60. AstraZeneca Pharmaceuticals LP Class II Terminated 20160330
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82 Sagent Pharmaceuticals Inc Class II Terminated 20160330
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01 AGA Gas Inc Class II Terminated 20160330
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61 Pharmedium Services, LLC Class III Terminated 20160323
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61 Pharmedium Services, LLC Class III Terminated 20160323
Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006. Medical Park Homecare, Inc Class III Terminated 20160323