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-1000-2019 | 02-08-2019 | MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 8,500 54 mL bags | Class II | Terminated |
| D-0997-2019 | 02-08-2019 | Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 2,840 4mL syringes | Class II | Terminated |
| D-1112-2019 | 02-08-2019 | Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027 | Unapproved new drug | McDaniel Life-Line LLC / Unknown | Class II | Terminated |
| D-0998-2019 | 02-08-2019 | MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 250 52 mL bags | Class II | Terminated |
| D-0999-2019 | 02-08-2019 | MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05. | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself. | Avella of Deer Valley, Inc. Store 38 / 4,950 54 mL bags | Class II | Terminated |
| D-0514-2019 | 02-07-2019 | Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37 | Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. | ACP Nimble Buyer, Inc. / 58,176 units | Class III | Terminated |
| D-0496-2019 | 02-06-2019 | Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72 | Labeling: Incorrect expiration date. | Advanced Pharma Inc. / 100 syringes | Class II | Terminated |
| D-0497-2019 | 02-06-2019 | Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99. | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. / 12 bags | Class III | Terminated |
| D-1064-2019 | 02-06-2019 | Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / 105 units | Class II | Terminated |
| D-0498-2019 | 02-06-2019 | Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99. | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. / 672 bags | Class III | Terminated |
| D-0499-2019 | 02-06-2019 | Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50. | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. / 1460 bottles | Class III | Terminated |
| D-0995-2019 | 02-06-2019 | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA. Package NDCs: 43598-509-30; 43598-509-90; 43598-509-10; 43598-510-30; 43598-510-90; 43598-510-10 | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. | Dr. Reddy's Laboratories, Inc. / 40,592, 90 and 1,000 count bottles | Class III | Terminated |
| D-1062-2019 | 02-06-2019 | Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33 Package NDCs: 47593-489-26; 47593-489-33; 47593-489-49; 47593-489-31; 47593-489-55 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / 30 units | Class II | Terminated |
| D-1060-2019 | 02-06-2019 | Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. Package NDCs: 47593-487-33; 47593-487-31; 47593-487-41; 47593-487-26; 47593-487-49; 47593-487-56; 47593-487-55; 47593-487-65; 47593-487-38; 47593-487-35; 47593-487-11; 47593-487-91 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / a) 22 units b) 314 units c) 3511 units | Class II | Terminated |
| D-1063-2019 | 02-06-2019 | Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / 67 units | Class II | Terminated |
| D-1061-2019 | 02-06-2019 | Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. Package NDCs: 47593-488-33; 47593-488-31; 47593-488-32; 47593-488-26; 47593-488-56; 47593-488-41; 47593-488-49 | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor. | Ecolab Inc / a) 118 units, b) 3,783 units | Class II | Terminated |
| D-0511-2019 | 02-04-2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01. | Failed Stability Specification: out of specification results for Sodium Perborate | Akorn Inc / 78120 dropper bottles | Class II | Terminated |
| D-0509-2019 | 02-04-2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09 | CGMP Deviations | ICU Medical Inc / 475320 bags | Class II | Terminated |
| D-0424-2019 | 02-01-2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23. Package NDCs: 0037-0245-23 | Defective Container: Potential for broken glass in the neck area of the glass bottles. | Mylan Pharmaceuticals Inc. / 10,390 bottles | Class II | Terminated |
| D-0484-2019 | 02-01-2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01 Package NDCs: 68180-422-01 | Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained. | Lupin Pharmaceuticals Inc. / 43,860 3ml bottles | Class III | Terminated |
| D-1059-2019 | 02-01-2019 | Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30 | Presence of Particulate Matter: particulate matter identified as copper salts | Mylan Institutional Inc / 11,964 cartons of 30 vials | Class I | Terminated |
| D-0507-2019 | 01-31-2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01 Package NDCs: 55111-533-30; 55111-533-60; 55111-533-01; 55111-533-05; 55111-533-79; 55111-533-78 | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Dr. Reddy's Laboratories, Inc. / 10,656 bottles | Class II | Terminated |
| D-0490-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 22 bottles | Class III | Terminated |
| D-0489-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 390 bottles | Class III | Terminated |
| D-0487-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 1023 bottles | Class III | Terminated |
| D-0491-2019 | 01-30-2019 | Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01. | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 23,884 bottles | Class III | Terminated |
| D-0488-2019 | 01-30-2019 | Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Package NDCs: 0187-0795-30; 0187-0795-42; 0187-0795-49; 0187-0796-30; 0187-0796-42; 0187-0796-49; 0187-0796-50; 0187-0797-30; 0187-0797-42; 0187-0797-49; 0187-0798-30; 0187-0798-42; 0187-0799-42 | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. | Valeant Pharmaceuticals North America LLC / 206 bottles | Class III | Terminated |
| D-0508-2019 | 01-29-2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407 | Lack of assurance of sterility. | US Compounding Inc / 1686 syringes | Class II | Terminated |
| D-0429-2019 | 01-28-2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA. | Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities. | Lupin Pharmaceuticals Inc. / 9,930 bottles | Class III | Terminated |
| D-0515-2019 | 01-25-2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701. | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. | Akorn Inc / a) 4896 tubes; b) 5064 tubes | Class III | Terminated |
| D-0500-2019 | 01-25-2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil | Natures Rx / 211 | Class I | Terminated |
| D-0422-2019 | 01-24-2019 | BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41 Package NDCs: 49708-754-41 | Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. | Sun Pharmaceutical Industries, Inc. / 69840 bottles | Class II | Terminated |
| D-0482-2019 | 01-24-2019 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303. | Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY. | US Compounding Inc / 1931 syringes | Class II | Terminated |
| D-0428-2019 | 01-18-2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. | Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification. | Mylan Pharmaceuticals Inc. / 88,090 bottles | Class II | Terminated |
| D-1013-2019 | 01-18-2019 | Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20 | Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 10,281 UD cartons | Class II | Terminated |
| D-0409-2019 | 01-18-2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09 Package NDCs: 43547-374-03; 43547-374-09; 43547-374-50; 43547-375-03; 43547-375-09; 43547-375-50; 43547-376-03; 43547-376-09; 43547-376-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 19800 bottles | Class II | Completed |
| D-0410-2019 | 01-18-2019 | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 2177 bottles | Class II | Completed |
| D-0413-2019 | 01-18-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 87505 bottles | Class II | Completed |
| D-0412-2019 | 01-18-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 12294 bottles | Class II | Completed |
| D-0411-2019 | 01-18-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03 Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Prinston Pharmaceutical Inc / 32692 bottles | Class II | Completed |
| D-1078-2019 | 01-16-2019 | NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343 | Labeling: Label mix-up | KRS Global Biotechnology, Inc / 190 250 mL bags | Class II | Terminated |
| D-1079-2019 | 01-16-2019 | NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481 | Labeling: Label mix-up | KRS Global Biotechnology, Inc / 433 250 mL bags | Class II | Terminated |
| D-1007-2019 | 01-16-2019 | Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10 | Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps. | Rx Pak Division of McKesson Corporation / 29,622 Blister Cards | Class II | Terminated |
| D-0389-2019 | 01-15-2019 | Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10 | Presence of Foreign Substance: Product complaint of black speckles observed on tablets. | Dr. Reddy's Laboratories, Inc. / 118 bottles | Class II | Terminated |
| D-0430-2019 | 01-15-2019 | HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65 | Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL) | Advanced Pharma Inc. / 160 syringes | Class II | Terminated |
| D-0495-2019 | 01-15-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. / 35,280 bottles | Class II | Terminated |
| D-0494-2019 | 01-15-2019 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. / 35,328 bottles | Class II | Terminated |
| D-0390-2019 | 01-15-2019 | Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60. Package NDCs: 43386-069-60 | Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient. | LUPIN SOMERSET / 24,180 bottles | Class II | Terminated |
| D-0493-2019 | 01-15-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. / 46,080 bottles | Class II | Terminated |
| D-0492-2019 | 01-11-2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86 Package NDCs: 33342-321-86; 33342-321-39; 3334203218 | Defective Container; complaints of leakage. | Oxalis Labs / 53,358 bottles | Class III | Terminated |
| D-1466-2019 | 01-10-2019 | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152. | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | MAJOR PHARMACEUTICALS / 3,102 Cartons (310,200 tablets) | Class II | Terminated |
| D-0802-2020 | 01-10-2019 | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704 | Presence of Particulate Matter: filmy/cloudy particulate observed in vial. | McGuff Compounding Pharmacy Services, Inc. / 146 30 ml vials were dispensed | Class II | Terminated |
| D-0423-2019 | 01-09-2019 | Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01 Package NDCs: 68180-123-01; 68180-123-02; 68180-124-01; 68180-124-02; 68180-440-01; 68180-440-02; 68180-441-01; 68180-441-02 | CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product. | Lupin Pharmaceuticals Inc. / 14,400 bottles | Class II | Terminated |
| D-0388-2019 | 01-08-2019 | 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644 | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil | Happy Together, Inc. / N/A | Class I | Terminated |
| D-0380-2019 | 01-07-2019 | Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02 | CGMP Deviation; manufacturing batch record could not be located | Lupin Pharmaceuticals Inc. / 7,215 bottles | Class II | Terminated |
| D-0373-2019 | 01-03-2019 | Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton] Package NDCs: 47335-931-40; 47335-931-44; 47335-932-40; 47335-932-44 | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. | Sun Pharmaceutical Industries, Inc. / 1,384 cartons, 13,840 vials | Class I | Terminated |
| D-0372-2019 | 01-03-2019 | Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton] Package NDCs: 47335-931-40; 47335-931-44; 47335-932-40; 47335-932-44 | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. | Sun Pharmaceutical Industries, Inc. / 12,534 cartons, 125,340 vials | Class I | Terminated |
| D-0376-2019 | 01-02-2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. | Lupin Pharmaceuticals Inc. / 287,784 bottles | Class II | Terminated |
| D-0351-2019 | 01-02-2019 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. | Baxter Healthcare Corporation / 29,370 bags | Class II | Terminated |
| D-0375-2019 | 01-02-2019 | Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. | Lupin Pharmaceuticals Inc. / 287,784 bottles | Class II | Terminated |
| D-0406-2019 | 01-02-2019 | Cyclosporin liquid 0.05%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0402-2019 | 01-02-2019 | Vitamin B12 liquid 1000mcg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 150 ml | Class II | Terminated |
| D-0404-2019 | 01-02-2019 | Cyclosporin liquid 0.5%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0394-2019 | 01-02-2019 | Glutathione liquid, 100mg/ml | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 60 ml | Class II | Terminated |
| D-0399-2019 | 01-02-2019 | MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 310 ml | Class II | Terminated |
| D-0408-2019 | 01-02-2019 | Lidocaine gel 1%, RX, plastic dropper | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0395-2019 | 01-02-2019 | HCG liquid, 1000u/ml, RX, glass vial, various | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 30 ml | Class II | Terminated |
| D-0392-2019 | 01-02-2019 | Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 830 ml | Class II | Terminated |
| D-0393-2019 | 01-02-2019 | Epinephrine liquid 1:1000, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 50 ml | Class II | Terminated |
| D-0398-2019 | 01-02-2019 | Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 50 ml | Class II | Terminated |
| D-0396-2019 | 01-02-2019 | Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 20 ml | Class II | Terminated |
| D-0400-2019 | 01-02-2019 | Methocarbamol liquid 100mg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 300 ml | Class II | Terminated |
| D-0397-2019 | 01-02-2019 | Lidocaine gel 2%, RX, plastic dropper | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 125 ml | Class II | Terminated |
| D-0403-2019 | 01-02-2019 | Cyclosporin liquid 1%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0401-2019 | 01-02-2019 | Testosteron Cypionate liquid 200mg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 200 ml | Class II | Terminated |
| D-0405-2019 | 01-02-2019 | Cyclosporin liquid 0.2%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0407-2019 | 01-02-2019 | Glutathione liquid, 200mg/ml, Rx | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0374-2019 | 01-02-2019 | 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478. | Subpotent | PharMEDium Services, LLC. / 7,711 syringes | Class II | Terminated |
| D-0352-2019 | 01-02-2019 | Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31 | Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle | Heritage Pharmaceuticals, Inc. / 5,060 units | Class II | Terminated |
| D-0365-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 23,016 bottles | Class II | Ongoing |
| D-0362-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30. Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 60,417 bottles | Class II | Ongoing |
| D-1037-2019 | 12-31-2018 | Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-1039-2019 | 12-31-2018 | Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-1035-2019 | 12-31-2018 | Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-1038-2019 | 12-31-2018 | Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-0370-2019 | 12-31-2018 | Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90. Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 20,604 bottles | Class II | Ongoing |
| D-0363-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30. Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 27,688 bottles | Class II | Ongoing |
| D-0369-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 53,064 bottles | Class II | Ongoing |
| D-0367-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 111,239 bottles | Class II | Ongoing |
| D-0361-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30 Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 18,408 bottles | Class II | Ongoing |
| D-0368-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 32,160 bottles | Class II | Ongoing |
| D-0364-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30. Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 55,788 bottles | Class II | Ongoing |
| D-1036-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30 Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-0366-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Aurobindo Pharma USA Inc. / 92,616 bottles | Class II | Ongoing |
| D-0350-2019 | 12-26-2018 | Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ Package NDCs: 68462-711-71; 68462-711-88 | Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator | Glenmark Pharmaceuticals Inc., USA / 96,240 applicators | Class II | Terminated |
| D-0391-2019 | 12-26-2018 | LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24 Package NDCs: 53943-123-12; 53943-123-24 | Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets. | Sun Pharmaceutical Industries, Inc. / 5040 cartons | Class III | Terminated |
| D-0346-2019 | 12-21-2018 | 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, NDC 43386-450-11. Package NDCs: 43386-450-11 | Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. | LUPIN SOMERSET / 23,460 bottles | Class II | Terminated |
| D-0483-2019 | 12-20-2018 | COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10 | Failed Stability Specifications: out of specification results for opalescence at 7 month stability study. | Akorn Inc / 30,794 bottles | Class III | Terminated |
| D-0505-2019 | 12-20-2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Torrent Pharma Inc. / 18,780 bottles | Class II | Ongoing |
| D-0504-2019 | 12-20-2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Torrent Pharma Inc. / 18,852 bottles | Class II | Ongoing |
