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-1175-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 19109 bottles | Class II | Terminated |
| D-1174-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 24796 bottles | Class II | Terminated |
| D-1177-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 19623 bottles | Class II | Terminated |
| D-1097-2018 | 07-18-2018 | Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 2 bottles | Class II | Terminated |
| D-1095-2018 | 07-18-2018 | Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 68 bottles | Class II | Terminated |
| D-1098-2018 | 07-18-2018 | Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 14 bottles | Class II | Terminated |
| D-1096-2018 | 07-18-2018 | Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 43 bottles | Class II | Terminated |
| D-1110-2018 | 07-17-2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 524 bottles | Class II | Ongoing |
| D-1108-2018 | 07-17-2018 | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 666 bottles | Class II | Ongoing |
| D-1109-2018 | 07-17-2018 | Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 178 bottles | Class II | Ongoing |
| D-1111-2018 | 07-17-2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 531 bottles | Class II | Ongoing |
| D-1049-2018 | 07-17-2018 | Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211. | CGMP Deviations | Longbow First Aid Products Manufactory / 14,400 bottles | Class II | Terminated |
| D-1021-2018 | 07-17-2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 3 HDPE 90-count bottles (270 tablets) | Class II | Terminated |
| D-1020-2018 | 07-17-2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 4 HDPE 90-count bottles (360 tablets) | Class II | Terminated |
| D-1048-2018 | 07-17-2018 | Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY | CGMP Deviations | Longbow First Aid Products Manufactory / 30,000 bottles | Class II | Terminated |
| D-0989-2018 | 07-16-2018 | Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 13,555 90-count bottles; 2,892 500-count bottles | Class II | Ongoing |
| D-0988-2018 | 07-16-2018 | Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 15,347 90-count bottles, 8,378 1000-count bottles | Class II | Ongoing |
| D-0986-2018 | 07-16-2018 | Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 8,046 30-count bottles, 20,841 90-count bottles | Class II | Ongoing |
| D-1074-2018 | 07-16-2018 | Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89 | API material used in the manufacturing of the product did not receive regulatory approval prior to release. | Teva Pharmaceuticals USA / 13,715 120-count bottles | Class II | Terminated |
| D-0987-2018 | 07-16-2018 | Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 30,793 90-count bottles, 1,158 1000-count bottles | Class II | Ongoing |
| D-0982-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 195,234 bottles | Class II | Ongoing |
| D-0984-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 64,168 bottles | Class II | Ongoing |
| D-0985-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 164,922 bottles | Class II | Ongoing |
| D-0983-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 99,554 bottles | Class II | Ongoing |
| D-0981-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 56,603 bottles | Class II | Ongoing |
| D-0970-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0976-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0975-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0971-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0969-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0972-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0974-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0968-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0973-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0977-2018 | 07-12-2018 | Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40 Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. | Sun Pharmaceutical Industries, Inc. / 5215 units | Class II | Terminated |
| D-1031-2018 | 07-11-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06. | Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor. | Renaissance Lakewood, LLC / 3000 bags | Class III | Terminated |
| D-1032-2018 | 07-11-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10. | Failed Stability Specifications: lot out of specification for elevated water vapor. | Renaissance Lakewood, LLC / 3664 bags | Class III | Terminated |
| D-1033-2018 | 07-11-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06. | Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. | Renaissance Lakewood, LLC / 12088 bags | Class III | Terminated |
| D-1041-2018 | 07-10-2018 | Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20. Package NDCs: 68682-652-20; 68682-655-20; 68682-650-20 | Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton. | Valeant Pharmaceuticals North America LLC / 306 cartons | Class III | Terminated |
| D-0978-2018 | 07-09-2018 | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01 | Subpotent Drug | Mylan Pharmaceuticals Inc. / 28,436 bottles | Class III | Terminated |
| D-0909-2018 | 07-05-2018 | Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60. Package NDCs: 0591-2990-60 | Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants. | Teva Pharmaceuticals USA / 27,803 bottles | Class II | Terminated |
| D-0920-2018 | 07-05-2018 | alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4. | Incorrect Product Formulation: wrong sunscreen product in the package. | The Hain Celestial Group, Inc. - Worldwide HQ / 47,128 tubes | Class II | Terminated |
| D-0925-2018 | 07-05-2018 | Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00 Package NDCs: 0024-5924-10; 0024-5925-01; 0024-5925-05; 0024-5925-00; 0024-5926-05 | Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. | Sanofi-Aventis U.S. LLC / 3214 prefilled pens | Class II | Ongoing |
| D-0924-2018 | 07-03-2018 | Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02 Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet. | Sun Pharmaceutical Industries, Inc. / 2508 bottles | Class II | Terminated |
| D-0917-2018 | 07-03-2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08. | CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. | Medgyn Products, Inc. / 2750 boxes | Class II | Terminated |
| D-0919-2018 | 07-03-2018 | Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007 | CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. | Medi-Fare Drug and Home Health Center / 1116 syringes | Class II | Terminated |
| D-1030-2018 | 07-02-2018 | Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30 Package NDCs: 55150-119-30; 55150-120-30; 55150-121-50 | Presence of Particulate Matter: identified as glass and silicone material | AuroMedics Pharma LLC / 73620 single-dose vials | Class I | Terminated |
| D-0918-2018 | 06-29-2018 | Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059 | Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. | SCA Pharmaceuticals / 3984 syringes | Class II | Terminated |
| D-0910-2018 | 06-29-2018 | Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02. | Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. | Fagron Compounding Services LLC dba Fagron Sterile Services / 840 prefilled syringes | Class I | Terminated |
| D-0911-2018 | 06-29-2018 | Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01. | Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. | Fagron Compounding Services LLC dba Fagron Sterile Services / 390 prefilled syringes | Class I | Terminated |
| D-0927-2018 | 06-28-2018 | Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11 Package NDCs: 43386-450-11 | Subpotent Drug and Failed Content Uniformity. | LUPIN SOMERSET / 3456 cartons | Class II | Terminated |
| D-1023-2018 | 06-28-2018 | Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01. | Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination. | PFIZER / 234,680 vials | Class II | Terminated |
| D-0991-2018 | 06-27-2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Aidarex Pharmaceuticals LLC / 61, 90-count bottles | Class III | Terminated |
| D-0992-2018 | 06-27-2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Aidarex Pharmaceuticals LLC / 25, 30-count bottles | Class III | Terminated |
| D-0990-2018 | 06-27-2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Aidarex Pharmaceuticals LLC / 11, 90-count bottles | Class III | Terminated |
| D-1122-2018 | 06-26-2018 | Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 789 50-count pouches, total of 39,450 capsules | Class I | Terminated |
| D-0980-2018 | 06-26-2018 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61. | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product. | MAJOR PHARMACEUTICALS / 5,933 cartons | Class III | Terminated |
| D-1125-2018 | 06-26-2018 | Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 545 50-count pouches, 27,250 capsules | Class I | Terminated |
| D-0979-2018 | 06-26-2018 | Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61. | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product. | MAJOR PHARMACEUTICALS / 3,397 cartons | Class III | Terminated |
| D-1124-2018 | 06-26-2018 | Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 681 12 mL-bottle | Class I | Terminated |
| D-1123-2018 | 06-26-2018 | Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3. | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 164 2oz bottles | Class I | Terminated |
| D-1126-2018 | 06-26-2018 | Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 553 50-count pouch, 27,650 capsules | Class I | Terminated |
| D-0922-2018 | 06-25-2018 | Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500 | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC / 17,610 mL total dispensed in 10 mL and 30 mL vials | Class II | Terminated |
| D-0923-2018 | 06-25-2018 | Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500 | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC / 191 vials | Class II | Terminated |
| D-0921-2018 | 06-25-2018 | Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500 | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC / 19,040 mL total dispensed in 10 mL and 30 mL vials | Class II | Terminated |
| D-0915-2018 | 06-25-2018 | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose] | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant | AMERICAN HEALTH PACKAGING / 1285 cartons (cartons of 100 individual unit doses) | Class III | Terminated |
| D-0908-2018 | 06-22-2018 | eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9 | Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity | Eb5 Corporation / 4,632 tubes | Class II | Terminated |
| D-0916-2018 | 06-22-2018 | Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30. | CGMP Deviations | Akorn, Inc. / 89,507 vials | Class II | Terminated |
| D-1011-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1000-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / | Class I | Terminated |
| D-1012-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1008-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0995-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1001-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1006-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1013-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1005-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0997-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1007-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1016-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1014-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1010-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1004-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0996-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0994-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1015-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1003-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / | Class I | Terminated |
| D-0889-2018 | 06-20-2018 | fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72. | Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. | Advanced Pharma Inc. / 100 syringes | Class II | Terminated |
| D-0998-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1002-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1009-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0999-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0993-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0912-2018 | 06-19-2018 | Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. | Failed Impurities/Degradation Specifications | Wockhardt Limited / 31,710 tablets | Class III | Terminated |
| D-0913-2018 | 06-19-2018 | Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. | Failed Impurities/Degradation Specifications | Wockhardt Limited / 17,628 tablets | Class III | Terminated |
| D-1171-2018 | 06-15-2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15 | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Validus Pharmaceuticals, Inc. / 696 bottles | Class III | Terminated |
| D-1170-2018 | 06-15-2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59 | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Validus Pharmaceuticals, Inc. / 7864 bottles | Class III | Terminated |
| D-0905-2018 | 06-14-2018 | Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 196 bags | Class II | Terminated |
| D-0894-2018 | 06-14-2018 | Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 440 syringes | Class II | Terminated |
| D-0901-2018 | 06-14-2018 | Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 451 bags | Class II | Terminated |
