Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
D-0959-2016	12-11-2015	FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM	Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.	Reesna, Inc / 26,250 capsules	Class I	Terminated
D-0960-2016	12-11-2015	FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM	Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.	Reesna, Inc / 7,250 capsules	Class I	Terminated
D-0882-2016	12-09-2015	Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010	Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.	Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown	Class I	Terminated
D-0883-2016	12-09-2015	Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010	Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.	Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown	Class I	Terminated
D-0799-2016	12-08-2015	Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1 Package NDCs: 58468-0160-1; 58468-0160-2	Labeling: Incorrect or Missing Lot and/or Exp Date	Genzyme Corporation / 24 vials	Class III	Terminated
D-0650-2017	12-07-2015	Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09 Package NDCs: 68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09	Failed Impurities/Degradation Specifications; Impurity A	Lupin Pharmaceuticals Inc. / 15,168 bottes	Class III	Terminated
D-0519-2016	12-03-2015	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 Package NDCs: 0173-0682-20; 0173-0682-24	Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.	GlaxoSmithKline, LLC / 128,704 Inhalers	Class II	Terminated
D-0860-2016	12-03-2015	LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com	Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.	Lipo Escultura Corp. / unknown	Class I	Terminated
D-0520-2016	12-02-2015	Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. Package NDCs: 0025-2752-31; 0025-2762-31; 0025-2732-31; 0025-2742-31; 0025-2742-51	Failed Dissolution Specification	Pfizer Inc. / a) 4005 bottles, b) 104 bottles	Class III	Terminated
D-0779-2016	11-29-2015	Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01	cGMP Deviations; trailer may not have met GMP requirements prior to filling	AGA Gas Inc / 1,500 gallons	Class II	Terminated
D-0510-2016	11-25-2015	MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Golden State Medical Supply Inc. / a) 737 Bottles; b) 3863 Bottles	Class III	Terminated
D-0509-2016	11-25-2015	MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Golden State Medical Supply Inc. / 1136 Bottles	Class III	Terminated
D-0909-2016	11-23-2015	SUPER HERBS 350 mg, 30 capsules per bottle.	Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.	Super Herbs / 9 bottles	Class I	Terminated
D-0773-2016	11-19-2015	NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL	Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.	Teva Pharmaceuticals USA / 576 bottles	Class III	Terminated
D-0510-2019	11-12-2015	tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560.	Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.	Mariposa Labs LLC / 1654 jars	Class II	Terminated
D-0566-2016	11-12-2015	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. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02	Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.	Teva Pharmaceuticals USA / 9,717 bottles	Class II	Terminated
D-0511-2016	11-11-2015	Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 65 Vials	Class II	Terminated
D-0517-2016	11-11-2015	Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 4 Vials	Class II	Terminated
D-0656-2016	11-11-2015	SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.	Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.	Fagron, Inc / 88 Bottles	Class II	Terminated
D-0513-2016	11-11-2015	Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 1 Vial	Class II	Terminated
D-0515-2016	11-11-2015	Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 1625 Vials	Class II	Terminated
D-0514-2016	11-11-2015	Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 1 Vial	Class II	Terminated
D-0512-2016	11-11-2015	Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 60 Vials	Class II	Terminated
D-0516-2016	11-11-2015	Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.	RemedyRepack Inc. / 106 Vials	Class II	Terminated
D-0654-2016	11-11-2015	SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.	Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.	Fagron, Inc / 44 Bottles	Class II	Terminated
D-0655-2016	11-11-2015	SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.	Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.	Fagron, Inc / 148 Bottles	Class II	Terminated
D-0546-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 21 syringes	Class II	Terminated
D-0551-2016	11-10-2015	Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 7 bags	Class II	Terminated
D-0549-2016	11-10-2015	Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 27 syringes	Class II	Terminated
D-0540-2016	11-10-2015	IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 1 bag	Class II	Terminated
D-0555-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 9 bags	Class II	Terminated
D-0527-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 49 syringes	Class II	Terminated
D-0532-2016	11-10-2015	Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 40 Minibags	Class II	Terminated
D-0558-2016	11-10-2015	3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 87 bags	Class II	Terminated
D-0545-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 23 syringes	Class II	Terminated
D-0529-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 26 Accuflo bags	Class II	Terminated
D-0554-2016	11-10-2015	Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 26 Minibags	Class II	Terminated
D-0552-2016	11-10-2015	Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 1 bag	Class II	Terminated
D-0548-2016	11-10-2015	Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 63 Minibags	Class II	Terminated
D-0538-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 19 bags	Class II	Terminated
D-0536-2016	11-10-2015	Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 35 Minibags	Class II	Terminated
D-0550-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 30 Accuflo bags	Class II	Terminated
D-0547-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 5 bags	Class II	Terminated
D-0543-2016	11-10-2015	Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 23 syringes	Class II	Terminated
D-0557-2016	11-10-2015	0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 7 bags	Class II	Terminated
D-0537-2016	11-10-2015	Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 14 Accuflo bags	Class II	Terminated
D-0542-2016	11-10-2015	Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 23 syringes	Class II	Terminated
D-0544-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 30 syringes	Class II	Terminated
D-0528-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 95 Accuflo bags	Class II	Terminated
D-0531-2016	11-10-2015	L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 14 syringes	Class II	Terminated
D-0534-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 1 bag	Class II	Terminated
D-0485-2016	11-10-2015	Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53	Labeling: Not elsewhere classified. NDC number is incorrect on the container.	Northwind Pharmaceuticals LLC / 40 Bottles	Class III	Terminated
D-0535-2016	11-10-2015	0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 7 bags	Class II	Terminated
D-0530-2016	11-10-2015	Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 52 Minibags	Class II	Terminated
D-0541-2016	11-10-2015	Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 20 syringes	Class II	Terminated
D-0556-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 43 bags	Class II	Terminated
D-0539-2016	11-10-2015	Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 46 Minibags	Class II	Terminated
D-0533-2016	11-10-2015	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	Lack of Assurance of Sterility	Walgreens Infusion Services / 34 Accuflo bags	Class II	Terminated
D-0526-2016	11-10-2015	Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 73 syringes	Class II	Terminated
D-0553-2016	11-10-2015	Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045	Lack of Assurance of Sterility	Walgreens Infusion Services / 7 Accuflo bags	Class II	Terminated
D-0573-2016	11-09-2015	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.	Presence of Foreign Substance	Freedom Pharmaceuticals Inc / (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers	Class II	Terminated
D-0669-2016	11-06-2015	Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.	Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).	Glades Drugs Inc. / 7800 capsules	Class I	Ongoing
D-0582-2016	11-04-2015	Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC / N/A	Class II	Terminated
D-0584-2016	11-04-2015	Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC / N/A	Class II	Terminated
D-0720-2016	11-04-2015	Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30 Package NDCs: 55111-663-30; 55111-663-01; 55111-663-05; 55111-663-79; 55111-663-81; 55111-664-30; 55111-664-01; 55111-664-05; 55111-664-79; 55111-664-81; 55111-665-30; 55111-665-01; 55111-665-05; 55111-665-79; 55111-665-81	Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.	Dr. Reddy's Laboratories, Inc. / 4383 bottles	Class III	Terminated
D-0719-2016	11-04-2015	Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30 Package NDCs: 55111-663-30; 55111-663-01; 55111-663-05; 55111-663-79; 55111-663-81; 55111-664-30; 55111-664-01; 55111-664-05; 55111-664-79; 55111-664-81; 55111-665-30; 55111-665-01; 55111-665-05; 55111-665-79; 55111-665-81	Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.	Dr. Reddy's Laboratories, Inc. / 9,155 bottles	Class III	Terminated
D-0721-2016	11-04-2015	Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30 Package NDCs: 55111-663-30; 55111-663-01; 55111-663-05; 55111-663-79; 55111-663-81; 55111-664-30; 55111-664-01; 55111-664-05; 55111-664-79; 55111-664-81; 55111-665-30; 55111-665-01; 55111-665-05; 55111-665-79; 55111-665-81	Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.	Dr. Reddy's Laboratories, Inc. / 11,123 bottles	Class III	Terminated
D-0581-2016	11-04-2015	Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC / N/A	Class II	Terminated
D-0583-2016	11-04-2015	Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC / N/A	Class II	Terminated
D-0235-2016	11-02-2015	Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 4,609 Packages	Class III	Terminated
D-0563-2016	10-30-2015	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.	Failed Impurities/Degradation Specifications: Out of specifications results for impurities.	Avantor Performance Materials Inc / 265 Drums	Class III	Terminated
D-0564-2016	10-29-2015	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.	Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).	PQ Corporation / 41,650 lbs. (833 bags)	Class III	Terminated
D-0565-2016	10-29-2015	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	Presence of Particulate Matter	Amerisource Health Services / 2,784 cartons (278,400 capsules)	Class II	Terminated
D-0872-2016	10-28-2015	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company	Defective Delivery System; potential to have inaccurate dosage delivery	Sanofi-Aventis U.S. LLC / 383,900 prefilled syringes	Class I	Terminated
D-0873-2016	10-28-2015	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company	Defective Delivery System; potential to have inaccurate dosage delivery	Sanofi-Aventis U.S. LLC / 159,000 prefilled injectors	Class I	Terminated
D-0518-2016	10-27-2015	Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.	Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.	Steris Corp / 3 cases - 54 bottles	Class II	Terminated
D-0391-2016	10-27-2015	Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.	Geritrex Corp / 1,032 tubes	Class II	Terminated
D-0390-2016	10-27-2015	Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.	Geritrex Corp / 9,948 tubes: 3 oz(8,832), 7 oz(1,116)	Class II	Terminated
D-0392-2016	10-27-2015	GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.	Geritrex Corp / 844,704 suppositories	Class II	Terminated
D-0393-2016	10-27-2015	Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550	Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.	Geritrex Corp / 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350	Class II	Terminated
D-0234-2016	10-26-2015	Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Par Pharmaceutical Inc. / a) 387,100 Bottles; b) 63,572 Bottles	Class III	Terminated
D-0233-2016	10-26-2015	Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Par Pharmaceutical Inc. / a) 162,385 Bottles; b) 6949 Bottles	Class III	Terminated
D-0181-2016	10-21-2015	Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10	Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle	Breckenridge Pharmaceutical, Inc / 595 Bottles	Class III	Terminated
D-0162-2016	10-21-2015	RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.	Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.	Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 61,146 Bottles	Class III	Terminated
D-0521-2016	10-20-2015	Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98 Package NDCs: 0093-8238-56; 0093-8238-98; 0093-8232-56; 0093-8232-98	Labeling: Incorrect or Missing Lot AND/OR Exp Date.	Teva Pharmaceutical Industries / 3536 bottles	Class III	Terminated
D-0524-2016	10-19-2015	HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741	Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.	Oasis Medical, Inc. / 14,852 units	Class III	Terminated
D-0522-2016	10-19-2015	HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741	Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.	Oasis Medical, Inc. / 15,301 units	Class III	Terminated
D-0523-2016	10-19-2015	HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741	Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.	Oasis Medical, Inc. / 3,358 units	Class III	Terminated
D-0403-2016	10-19-2015	Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 4 containers	Class II	Terminated
D-0474-2016	10-19-2015	Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0483-2016	10-19-2015	Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0424-2016	10-19-2015	Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0481-2016	10-19-2015	Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 16 containers	Class II	Terminated
D-0458-2016	10-19-2015	Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0439-2016	10-19-2015	Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 vial	Class II	Terminated
D-0475-2016	10-19-2015	HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 3 vials	Class II	Terminated
D-0451-2016	10-19-2015	Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 3 containers	Class II	Terminated
D-0404-2016	10-19-2015	Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 8 containers	Class II	Terminated
D-0468-2016	10-19-2015	Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 7 containers	Class II	Terminated
D-0401-2016	10-19-2015	Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 4 containers	Class II	Terminated