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-0289-2019 | 11-30-2018 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30 Package NDCs: 65862-854-30; 65862-855-30; 65862-856-30; 65862-857-30 | Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach). | Aurobindo Pharma USA Inc. / 4464 bottles | Class III | Terminated |
| D-0348-2019 | 11-30-2018 | NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 | Failed Impurities/Degradation Specifications:Out of specification for impurities. | VistaPharm, Inc. / 4,065,550 5 ml cups | Class III | Terminated |
| D-0347-2019 | 11-29-2018 | Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61. | Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL". | Advanced Pharma Inc. / 225 syringes | Class I | Terminated |
| D-0349-2019 | 11-27-2018 | Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40 Package NDCs: 68462-583-11; 68462-583-85; 68462-583-40; 68462-584-58; 68462-584-40; 68462-584-76; 68462-585-40; 68462-585-76; 68462-112-33; 3684625834 | Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack. | Glenmark Pharmaceuticals Inc., USA / 5,016 blister packs | Class III | Terminated |
| D-0307-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 41,572 bottles | Class II | Ongoing |
| D-0306-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 142,260 bottles | Class II | Ongoing |
| D-0310-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 31,079 bottles | Class II | Ongoing |
| D-0304-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 39,617 bottles | Class II | Ongoing |
| D-0309-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 37,957 bottles | Class II | Ongoing |
| D-0305-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 75,883 bottles | Class II | Ongoing |
| D-0303-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 120,394 bottles | Class II | Ongoing |
| D-0308-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 19,458 bottles | Class II | Ongoing |
| D-0336-2019 | 11-26-2018 | 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 Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen. | Tris Pharma Inc. / 19,488 bottles | Class II | Terminated |
| D-0335-2019 | 11-26-2018 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen. | Tris Pharma Inc. / 164,304 bottles | Class II | Terminated |
| D-0337-2019 | 11-26-2018 | 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. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen. | Tris Pharma Inc. / 20,736 bottles | Class II | Terminated |
| D-0295-2019 | 11-21-2018 | Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05 | Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | QuVa Pharma, Inc. / 168 bags | Class III | Terminated |
| D-0285-2019 | 11-20-2018 | Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408 | Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product | AVKARE Inc. / 1602 bags | Class II | Terminated |
| D-0314-2019 | 11-20-2018 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 12,840 bottles | Class II | Ongoing |
| D-0312-2019 | 11-20-2018 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 12,336 bottles | Class II | Ongoing |
| D-0318-2019 | 11-20-2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 48,302 bottles | Class II | Ongoing |
| D-0317-2019 | 11-20-2018 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 5,660 bottles | Class II | Ongoing |
| D-0315-2019 | 11-20-2018 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 63,213 bottles | Class II | Ongoing |
| D-0316-2019 | 11-20-2018 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 25,147 bottles | Class II | Ongoing |
| D-0313-2019 | 11-20-2018 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 24,709 bottles | Class II | Ongoing |
| D-0311-2019 | 11-20-2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 23,478 bottles | Class II | Ongoing |
| D-0343-2019 | 11-19-2018 | Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Pharm D Solutions, LLC / 85 vials | Class II | Terminated |
| D-0293-2019 | 11-16-2018 | FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 602 cartons | Class II | Terminated |
| D-0290-2019 | 11-16-2018 | fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 115 kits | Class II | Terminated |
| D-0292-2019 | 11-16-2018 | BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 803 units (400 kit and 403 30 ml bottles) | Class II | Terminated |
| D-0291-2019 | 11-16-2018 | SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 71 cartons | Class II | Terminated |
| D-0299-2019 | 11-15-2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620 Package NDCs: 63323-186-04; 63323-186-02; 63323-186-01; 63323-186-10; 63323-186-03; 63323-186-20 | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex. | Fresenius Kabi USA, LLC / 1,312,350 20 mL vials | Class I | Terminated |
| D-0298-2019 | 11-15-2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610 Package NDCs: 63323-186-04; 63323-186-02; 63323-186-01; 63323-186-10; 63323-186-03; 63323-186-20 | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex. | Fresenius Kabi USA, LLC / 23,745,300 10 mL vials | Class I | Terminated |
| D-0287-2019 | 11-14-2018 | Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1 Package NDCs: 67877-242-01; 67877-242-10; 67877-242-38; 67877-242-33; 67877-249-01; 67877-249-10; 67877-249-38; 67877-249-33; 67877-250-01; 67877-250-38; 67877-250-33; 67877-250-10; 67877-245-01; 67877-245-38; 67877-245-33; 67877-246-01; 67877-246-38; 67877-246-33; 67877-246-10; 67877-247-60; 67877-247-38; 67877-247-33; 67877-247-10; 67877-248-01; 67877-248-38; 67877-248-33; 67877-248-10 | Presence of Foreign Substance; metal shard found in tablet | Ascend Laboratories LLC / N/A | Class II | Terminated |
| D-0274-2019 | 11-09-2018 | Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41 Package NDCs: 47593-521-59; 47593-521-41; 47593-521-56; 47593-521-38; 47593-521-57; 47593-521-70 | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. | Ecolab Inc / 12,540 bottles | Class II | Terminated |
| D-0273-2019 | 11-09-2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11) | Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation." | AMERICAN HEALTH PACKAGING / 4508 blister packs | Class III | Terminated |
| D-0275-2019 | 11-09-2018 | Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59 | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. | Ecolab Inc / 14,108 bottles | Class II | Terminated |
| D-0282-2019 | 11-08-2018 | INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07 | Failed Stability Specification: out of specification for iron content. | ALLERGAN / 111,132 cartons/10 vials per carton | Class II | Terminated |
| D-0248-2019 | 11-08-2018 | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23 Package NDCs: 66733-948-23; 66733-958-23 | Labeling: Missing label; potential for missing primary container label on the vial. | Eli Lilly & Co / 9,380 vials | Class III | Terminated |
| D-0284-2019 | 11-07-2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard trays & HDPE 60 cc bottles in plastic bags, Repackaged NDC 70518-1087-01, 10 capsules in HDPE 60 cc bottles in cardboard trays. | Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine). | RemedyRepack Inc. / 3,148 capsules | Class III | Terminated |
| D-0283-2019 | 11-07-2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 Package NDCs: 55111-671-30; 55111-671-90; 55111-671-01; 55111-671-05; 55111-671-48; 55111-671-79; 55111-671-81; 55111-671-06; 55111-671-31; 55111-671-78 | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing. | Dr. Reddy's Laboratories, Inc. / 4,212 (30-count blister pack) | Class II | Terminated |
| D-0266-2019 | 11-06-2018 | Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post Street, San Francisco, CA 94104], [DG health brand NDC: 55910-717-72, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072] | Presence of foreign substance: Product found to contain metal particles. | L. Perrigo Company / 70,170 bottles | Class II | Terminated |
| D-0279-2019 | 11-06-2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031 | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing. | Breckenridge Pharmaceutical, Inc. / 9,193 bottles | Class III | Terminated |
| D-0286-2019 | 11-06-2018 | AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60 Package NDCs: 64764-080-60; 64764-080-40; 64764-240-60; 64764-240-10; 64764-240-40 | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. | Takeda Development Center Americas, Inc. / 69,075 60-count bottles (4,144,500 capsules) | Class III | Terminated |
| D-0250-2019 | 11-05-2018 | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0. | Non-Sterility: Product manufactured under non-sterile production conditions. | Kadesh International / 18,521 bottles | Class I | Terminated |
| D-0259-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00 | Cross Contamination with Other Products | Sandoz Inc / 7817 bottles | Class II | Terminated |
| D-0260-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00 | Cross Contamination with Other Products | Sandoz Inc / 5100 bottles | Class II | Terminated |
| D-0261-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00 | Cross Contamination with Other Products | Sandoz Inc / 1550 bottles | Class II | Terminated |
| D-0264-2019 | 11-02-2018 | IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. | Golden State Medical Supply Inc. / 15,917 bottles | Class II | Terminated |
| D-0386-2019 | 11-02-2018 | Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 339 kits (1 standard syringe / 1 IFU per kit) | Class II | Terminated |
| D-0263-2019 | 11-02-2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. | Golden State Medical Supply Inc. / 2,439 bottles | Class II | Terminated |
| D-0385-2019 | 11-02-2018 | Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 2,654 kits (6 syringes per kit / 1 IFU per kit) | Class II | Terminated |
| D-0265-2019 | 11-02-2018 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. | Golden State Medical Supply Inc. / 12,502 bottles | Class II | Terminated |
| D-0384-2019 | 11-02-2018 | curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 7,063 kits (1 syringe per kit / 1 IFU per kit) | Class II | Terminated |
| D-0383-2019 | 11-02-2018 | curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 1,283 kits (8 syringes per kit / 3 IFU's per kit) | Class II | Terminated |
| D-0258-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01 Package NDCs: 0781-1635-10; 0781-1635-01; 0781-1635-13; 0781-1556-01; 0781-1556-05; 0781-1556-10; 0781-1556-13; 0781-1695-13; 0781-1695-10; 0781-1695-01 | Cross Contamination with Other Products | Sandoz Inc / 18,832 bottles | Class II | Terminated |
| D-0257-2019 | 11-02-2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540 Package NDCs: 0185-0122-01; 0185-0122-10 | Cross Contamination with Other Products | Sandoz Inc / 14366 bottles | Class III | Terminated |
| D-0262-2019 | 11-02-2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01 | Cross Contamination with Other Products | Sandoz Inc / 23053 bottles | Class III | Terminated |
| D-0359-2019 | 11-01-2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Sandoz, Inc / 170 HDPE bottles | Class II | Ongoing |
| D-0379-2019 | 11-01-2018 | Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-amin Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016. Model 8600-01101 | Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance. | Bound Tree Medical, LLC / 747 kits | Class III | Terminated |
| D-0371-2019 | 11-01-2018 | curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Producs, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016 | Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance. | Bound Tree Medical, LLC / 84 kits | Class II | Terminated |
| D-0224-2019 | 10-31-2018 | BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24 | Lack of Assurance of Sterility | Avella of Deer Valley, Inc. Store 38 / 911 syringes | Class II | Terminated |
| D-0300-2019 | 10-29-2018 | Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03 | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. | Westminster Pharmaceuticals Llc / 1571 bottles | Class II | Terminated |
| D-0301-2019 | 10-29-2018 | Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03 | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. | Westminster Pharmaceuticals Llc / 2319 bottles | Class II | Terminated |
| D-0302-2019 | 10-29-2018 | Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03 | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. | Westminster Pharmaceuticals Llc / 3976 bottles | Class II | Terminated |
| D-0267-2019 | 10-29-2018 | Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 2,977 HDPE bottles | Class II | Terminated |
| D-0268-2019 | 10-29-2018 | Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 5,061 HDPE bottles | Class II | Terminated |
| D-0271-2019 | 10-29-2018 | GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 18,760 HDPE bottles | Class II | Terminated |
| D-0270-2019 | 10-29-2018 | GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 3,835 HDPE bottles | Class II | Terminated |
| D-1208-2019 | 10-29-2018 | Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60 | Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities | Akorn, Inc. / 58,393 jars | Class III | Terminated |
| D-0269-2019 | 10-29-2018 | Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 5,989 HDPE | Class II | Terminated |
| D-0272-2019 | 10-29-2018 | GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 30,194 HDPE bottles | Class II | Terminated |
| D-0319-2019 | 10-29-2018 | Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20. Package NDCs: 0407-1401-52; 0407-1411-10; 0407-1411-20; 0407-1412-10; 0407-1412-20; 0407-1412-50; 0407-1412-29; 0407-1412-30; 0407-1412-60; 0407-1412-33; 0407-1412-27; 0407-1412-49; 0407-1412-34; 0407-1412-28; 0407-1412-35; 0407-1413-11; 0407-1413-10; 0407-1413-59; 0407-1413-30; 0407-1413-50; 0407-1413-51; 0407-1413-61; 0407-1413-95; 0407-1413-98; 0407-1413-62; 0407-1413-99; 0407-1413-60; 0407-1413-63; 0407-1413-91; 0407-1413-53; 0407-1413-90; 0407-1413-65; 0407-1413-92; 0407-1413-66; 0407-1413-93; 0407-1413-96; 0407-1413-69; 0407-1414-21; 0407-1414-50; 0407-1414-51; 0407-1414-52; 0407-1414-89; 0407-1414-20; 0407-1414-90; 0407-1414-22; 0407-1414-53; 0407-1414-60; 0407-1414-91; 0407-1414-76; 0407-1414-03; 0407-1414-23; 0407-1414-93; 0407-1414-04; 0407-1414-94; 0407-1414-24; 0407-1414-80; 0407-1414-95; 0407-1415-09; 0407-1416-12 | Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles. | GE Healthcare Inc. Life Sciences / 1092 cartons | Class II | Terminated |
| D-0220-2019 | 10-26-2018 | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27. Package NDCs: 11084-010-40; 11084-010-27; 11084-010-12; 11084-010-20; 11084-010-05; 11084-010-01; 11084-010-55; 11084-010-96; 11084-010-66 | CGMP Deviations: Product was released to market prior to microbiological testing. | S.C. Johnson Professional / 869 cases | Class II | Terminated |
| D-0485-2019 | 10-26-2018 | Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52 Package NDCs: 43598-635-52; 43598-635-10; 43598-636-52; 43598-636-10; 43598-637-52; 43598-637-10; 3435986375 | Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL). | Dr. Reddy's Laboratories, Inc. / 2770 bags; 277 selling units | Class I | Terminated |
| D-0245-2019 | 10-26-2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. | RemedyRepack Inc. / 1 vial | Class III | Terminated |
| D-0221-2019 | 10-26-2018 | Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441. | CGMP Deviations: Product was released to market prior to microbiological testing. | S.C. Johnson Professional / 258 cases | Class II | Terminated |
| D-0127-2019 | 10-24-2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | Aurobindo Pharma Limited (Unit I) / 1724.8 kgs. | Class II | Terminated |
| D-0218-2019 | 10-23-2018 | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560. | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. | Janssen Pharmaceuticals, Inc. / a) 3,956 cartons; b) 1 carton | Class II | Terminated |
| D-0217-2019 | 10-23-2018 | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560. | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. | Janssen Pharmaceuticals, Inc. / 1,777 cartons | Class II | Terminated |
| D-0128-2019 | 10-22-2018 | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01 | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Boehringer Ingelheim Pharmaceuticals, Inc. / 1,380 100-count bottles | Class II | Terminated |
| D-0131-2019 | 10-19-2018 | Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 1,360 bags | Class II | Terminated |
| D-0133-2019 | 10-19-2018 | Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 360 bags | Class II | Terminated |
| D-0134-2019 | 10-19-2018 | Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 300 bags | Class II | Terminated |
| D-0129-2019 | 10-19-2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01 | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing. | Teva Pharmaceuticals USA / 53,451 bottles | Class II | Terminated |
| D-0135-2019 | 10-19-2018 | Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 300 bags | Class II | Terminated |
| D-0132-2019 | 10-19-2018 | Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 20 syringes | Class II | Terminated |
| D-0277-2019 | 10-19-2018 | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5. Package NDCs: 56062-106-08 | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 8328 bottles | Class II | Terminated |
| D-0278-2019 | 10-19-2018 | children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / | Class II | Terminated |
| D-0276-2019 | 10-19-2018 | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 12,432 bottles | Class II | Terminated |
| D-0239-2019 | 10-18-2018 | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684 | Presence of precipitate | Promise Pharmacy LLC / N/A | Class III | Terminated |
| D-0415-2019 | 10-18-2018 | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00 | Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. | H J Harkins Company Inc dba Pharma Pac / 84, 5 ml bottles | Class II | Terminated |
| D-0229-2019 | 10-17-2018 | Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0237-2019 | 10-17-2018 | Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0233-2019 | 10-17-2018 | Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0227-2019 | 10-17-2018 | Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0236-2019 | 10-17-2018 | Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0228-2019 | 10-17-2018 | Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0226-2019 | 10-17-2018 | Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0231-2019 | 10-17-2018 | Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0234-2019 | 10-17-2018 | Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
