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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
Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA Grato Holdings, Inc. Class II Terminated 20160127
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840. PD-Rx Pharmaceuticals, Inc. Class III Terminated 20160127
Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10. Freedom Pharmaceuticals Inc Class II Terminated 20160127
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01 Mutual Pharmaceutical Company, Inc. Class II Terminated 20160127
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60 Morton Grove Pharmaceuticals, Inc. Class III Terminated 20160127
IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 Amerita Specialty Infusion Services Class II Terminated 20160127
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 Amerita Specialty Infusion Services Class II Terminated 20160127
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01 National Vitamin Co Inc Class III Terminated 20160120
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011. Freedom Pharmaceuticals Inc Class II Terminated 20160120
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0. Teva Pharmaceuticals USA Class II Terminated 20160120
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01 Amerisource Health Services Class II Terminated 20160120
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482. PQ Corporation Class III Terminated 20160113
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600. Avantor Performance Materials Inc Class III Terminated 20160113
5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China Freedom Pharmaceuticals Inc Class III Terminated 20160113
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07. PD-Rx Pharmaceuticals, Inc. Class II Terminated 20160113
Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04. PD-Rx Pharmaceuticals, Inc. Class II Terminated 20160113
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01 PD-Rx Pharmaceuticals, Inc. Class II Terminated 20160106
3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack Walgreens Infusion Services Class II Terminated 20160106
Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106