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 October 09, 2026 and include a total of 18002 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
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-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-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-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-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-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-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-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-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-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-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-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-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-0447-2016	10-19-2015	PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 9 containers	Class II	Terminated
D-0452-2016	10-19-2015	Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 4 containers	Class II	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-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-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-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-0432-2016	10-19-2015	Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0472-2016	10-19-2015	17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 41 containers	Class II	Terminated
D-0418-2016	10-19-2015	Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 6 containers	Class II	Terminated
D-0417-2016	10-19-2015	Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 3 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-0482-2016	10-19-2015	Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	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-0450-2016	10-19-2015	Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 45 containers	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-0484-2016	10-19-2015	Salicylic Acid 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-0449-2016	10-19-2015	Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0479-2016	10-19-2015	Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 3 containers	Class II	Terminated
D-0410-2016	10-19-2015	Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0413-2016	10-19-2015	Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 17 containers	Class II	Terminated
D-0457-2016	10-19-2015	Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 75 containers	Class II	Terminated
D-0423-2016	10-19-2015	Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0400-2016	10-19-2015	Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0415-2016	10-19-2015	Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 34 containers	Class II	Terminated
D-0421-2016	10-19-2015	Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0478-2016	10-19-2015	Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 4 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
D-0476-2016	10-19-2015	Lipodissolve 100/50mg Inj 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-0466-2016	10-19-2015	Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0442-2016	10-19-2015	Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0411-2016	10-19-2015	M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 3 containers	Class II	Terminated
D-0396-2016	10-19-2015	AMP50/B121MG Complex Mix/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-0456-2016	10-19-2015	Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0436-2016	10-19-2015	Magnesium Sulfate 50% 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-0441-2016	10-19-2015	Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0464-2016	10-19-2015	Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 68 containers	Class II	Terminated
D-0433-2016	10-19-2015	Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0430-2016	10-19-2015	Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0477-2016	10-19-2015	Super B Complex 3X 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-0470-2016	10-19-2015	Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0420-2016	10-19-2015	Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0419-2016	10-19-2015	Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0467-2016	10-19-2015	Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/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-0437-2016	10-19-2015	Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 5 containers	Class II	Terminated
D-0471-2016	10-19-2015	Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0402-2016	10-19-2015	Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 9 containers	Class II	Terminated
D-0434-2016	10-19-2015	Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 4 containers	Class II	Terminated
D-0405-2016	10-19-2015	Furosemide 20 mg/mL svn 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-0425-2016	10-19-2015	Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 5 containers	Class II	Terminated
D-0399-2016	10-19-2015	Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0412-2016	10-19-2015	M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0422-2016	10-19-2015	Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0473-2016	10-19-2015	Sodium Chloride 0.9% 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-0409-2016	10-19-2015	Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 3 containers	Class II	Terminated
D-0428-2016	10-19-2015	HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona	Lack of Assurance of Sterility	Western Drug / 8 container	Class II	Terminated
D-0453-2016	10-19-2015	Squaric Acid 4% 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-0429-2016	10-19-2015	Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 2 containers	Class II	Terminated
D-0406-2016	10-19-2015	Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0469-2016	10-19-2015	VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 4 containers	Class II	Terminated
D-0440-2016	10-19-2015	Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 18 containers	Class II	Terminated
D-0454-2016	10-19-2015	Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 15 containers	Class II	Terminated
D-0394-2016	10-19-2015	Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 16 containers	Class II	Terminated
D-0460-2016	10-19-2015	Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 6 containers	Class II	Terminated
D-0407-2016	10-19-2015	Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0461-2016	10-19-2015	Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated
D-0444-2016	10-19-2015	Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938	Lack of Assurance of Sterility	Western Drug / 1 container	Class II	Terminated