Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1055-2020 | 03-09-2020 | Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. | Lupin Pharmaceuticals Inc. / 1,712 cartons | Class III | Terminated |
| D-1056-2020 | 03-09-2020 | Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. | Lupin Pharmaceuticals Inc. / 9,897 cartons | Class II | Terminated |
| D-1005-2020 | 03-06-2020 | Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433 | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle | H J Harkins Company Inc dba Pharma Pac / 11,973 tablets | Class II | Terminated |
| D-1059-2020 | 03-06-2020 | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01. | CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date. | Nostrum Laboratories Inc / 4722 bottles | Class II | Terminated |
| D-1260-2020 | 03-05-2020 | Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27 Package NDCs: 0093-5986-19; 0093-5986-27; 0093-5985-19; 0093-5985-27 | CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component. | Teva Pharmaceuticals USA / 600 cartons/2 auto-injector per carton | Class II | Terminated |
| D-1064-2020 | 03-05-2020 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451 | CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. | Fresenius Medical Care Holdings, Inc. / 32,592 bags | Class II | Terminated |
| D-1035-2020 | 03-04-2020 | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31 Package NDCs: 0603-5335-21; 0603-5335-32; 0603-5336-21; 0603-5337-21; 0603-5337-32; 0603-5337-15; 0603-5337-31; 0603-5338-21; 0603-5338-28; 0603-5338-32; 0603-5338-15; 0603-5338-31; 0603-5339-21; 0603-5339-28; 0603-5339-32 | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg | Par Pharmaceutical Inc. / 13008 bottles | Class III | Terminated |
| D-1251-2020 | 03-03-2020 | PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com. | Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone. | Yusef Manufacturing Laboratories, LLC / 12,983 tubes | Class II | Terminated |
| D-1042-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 9513 boxes | Class II | Terminated |
| D-1043-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 13761 boxes | Class II | Terminated |
| D-1045-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 7469 boxes | Class II | Terminated |
| D-0998-2020 | 03-02-2020 | Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01 | Product Mix-Up: A foreign tablet was found in bottle. | Mayne Pharma Inc / 8274 100-count bottles | Class II | Terminated |
| D-1044-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 11093 boxes | Class II | Terminated |
| D-0997-2020 | 02-28-2020 | Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01 | cGMP Deviation | Sunstar Guangzhou Ltd. / 260,000 tubes | Class II | Terminated |
| D-0995-2020 | 02-27-2020 | Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01 Package NDCs: 0069-0106-01 | Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button. | Pfizer Inc. / 24,714 vials | Class II | Terminated |
| D-1001-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / 115 cartons | Class III | Terminated |
| D-0999-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / 330 cartons | Class III | Terminated |
| D-1000-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / 1 carton | Class III | Terminated |
| D-1002-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / | Class III | Terminated |
| D-1010-2020 | 02-24-2020 | Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 3 doses | Class II | Terminated |
| D-1009-2020 | 02-24-2020 | Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 8 doses | Class II | Terminated |
| D-1007-2020 | 02-24-2020 | Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 1 20 ml syringe | Class II | Terminated |
| D-1008-2020 | 02-24-2020 | Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 16 doses | Class II | Terminated |
| D-1011-2020 | 02-24-2020 | Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 1 40 ml syringe | Class II | Terminated |
| D-1006-2020 | 02-24-2020 | Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 2x5 ml bottles | Class II | Terminated |
| D-1063-2020 | 02-24-2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98. | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. | Breckenridge Pharmaceutical, Inc / 900 Vials | Class III | Terminated |
| D-0860-2020 | 02-21-2020 | Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00. | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. | Akorn, Inc. / 24 tubes | Class III | Terminated |
| D-0861-2020 | 02-21-2020 | CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01 | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. | Akorn, Inc. / N/A | Class III | Terminated |
| D-0859-2020 | 02-21-2020 | Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35 | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. | Akorn, Inc. / 720 tubes | Class III | Terminated |
| D-0862-2020 | 02-20-2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22. Package NDCs: 0591-2245-22 | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. | Teva Pharmaceuticals USA / 3,695 bottles | Class II | Terminated |
| D-0866-2020 | 02-19-2020 | Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD | Failed Impurities/Degradation Specification; high out of specification results observed | Lupin Pharmaceuticals Inc. / 876 bottles | Class II | Terminated |
| D-1029-2020 | 02-17-2020 | Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08 Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08 | Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg. | Strides Pharma Science Limited / 2576 bottles | Class III | Terminated |
| D-0868-2020 | 02-14-2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256. | Labeling: Incorrect or Missing Lot and/or Expiration date. | AAA Pharmaceutical, Inc. / 3456 Bottles | Class III | Terminated |
| D-0855-2020 | 02-12-2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06 Package NDCs: 68180-246-06; 68180-249-06; 68180-249-09; 68180-249-02; 68180-247-06; 68180-247-09; 68180-248-06 | Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. | Lupin Pharmaceuticals Inc. / 6,294 bottles | Class II | Terminated |
| D-0856-2020 | 02-12-2020 | TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012 | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet. | Golden State Medical Supply Inc. / 379,043 100-ct bottles and 330,997 500-ct bottles | Class III | Terminated |
| D-0843-2020 | 02-10-2020 | Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34. | Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022. | Par Pharmaceutical Inc. / 9,936 cartons | Class III | Terminated |
| D-0863-2020 | 02-07-2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1 Package NDCs: 51672-4069-1; 51672-4069-2 | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. | Taro Pharmaceuticals U.S.A., Inc. / 29,172 8 Fl Oz bottles | Class I | Terminated |
| D-0852-2020 | 02-07-2020 | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20 Package NDCs: 65862-501-30; 65862-501-05; 65862-502-20; 65862-502-05; 65862-503-20; 65862-503-01 | Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie | AuroMedics Pharma LLC / 30432 bottles | Class II | Terminated |
| D-0853-2020 | 02-07-2020 | Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20. Package NDCs: 55150-292-01; 55150-293-02; 55150-294-05; 55150-295-20 | Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples). | AuroMedics Pharma LLC / 4600 Vials | Class III | Terminated |
| D-0848-2020 | 02-07-2020 | Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11 | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging / 1,879 cartons | Class II | Terminated |
| D-0849-2020 | 02-07-2020 | Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11 | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging / 3,720 cartons | Class II | Terminated |
| D-0842-2020 | 02-05-2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30. Package NDCs: 0069-2150-30; 0069-2170-30; 0069-2190-30; 0069-2260-30; 0069-2160-30; 0069-2180-30; 0069-2250-30; 0069-2270-30; 0069-6180-30; 0069-6323-30; 0069-6565-30; 0069-6747-30; 0069-7810-30; 0069-7232-30; 0069-7654-30; 0069-7476-30 | Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection. | Pfizer Inc. / 128 bottles | Class II | Terminated |
| D-0841-2020 | 02-05-2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30. Package NDCs: 0069-2150-30; 0069-2170-30; 0069-2190-30; 0069-2260-30; 0069-2160-30; 0069-2180-30; 0069-2250-30; 0069-2270-30; 0069-6180-30; 0069-6323-30; 0069-6565-30; 0069-6747-30; 0069-7810-30; 0069-7232-30; 0069-7654-30; 0069-7476-30 | Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection. | Pfizer Inc. / 141 bottles | Class II | Terminated |
| D-0858-2020 | 02-03-2020 | Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA Package NDCs: 0904-6730-60; 0904-6730-80; 0904-6730-59; 0904-6730-61 | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. | Contract Pharmacal Corporation / a) 1176 bottles b) 6,216 bottles | Class II | Terminated |
| D-0857-2020 | 02-03-2020 | Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8 | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. | Contract Pharmacal Corporation / 5472 bottles | Class II | Terminated |
| D-0835-2020 | 02-03-2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray). | Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility. | Pfizer Inc. / 38,676 trays | Class II | Terminated |
| D-0847-2020 | 01-31-2020 | New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 4080 8 FL Oz bottles | Class II | Terminated |
| D-0846-2020 | 01-31-2020 | Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 5387 6 Fl Oz bottles | Class II | Terminated |
| D-0845-2020 | 01-31-2020 | Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 5249 6 Fl Oz bottles | Class II | Terminated |
| D-0834-2020 | 01-31-2020 | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01. | cGMP Deviations | Zydus Pharmaceuticals USA Inc / 2207 Vials | Class II | Terminated |
| D-0829-2020 | 01-29-2020 | Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01 Package NDCs: 29300-468-05; 29300-468-10; 29300-468-50; 29300-468-01; 29300-136-01; 29300-136-05; 29300-136-10; 29300-136-50; 29300-137-01; 29300-137-05; 29300-137-10; 29300-137-25; 29300-135-01; 29300-135-05; 29300-135-10; 29300-135-50 | Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label. | UNICHEM PHARMACEUTICALS USA INC / 19161600 units | Class III | Terminated |
| D-0851-2020 | 01-28-2020 | Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545 | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet. | Teva Pharmaceuticals USA / 2,044,497 bottles | Class III | Terminated |
| D-0832-2020 | 01-28-2020 | Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11. | Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg. | Graviti Pharmaceuticals Private Limited / 29,056 bottles | Class II | Terminated |
| D-0850-2020 | 01-28-2020 | Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39. | Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity. | NCS Healthcare of Kentucky Inc / 6929 blister cards | Class II | Terminated |
| D-0840-2020 | 01-28-2020 | Kushim Tablets (Gushim) 45-count packages, Label in foreign language | Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine | B AND A TRADING CORPORATION / 40 packages | Class II | Terminated |
| D-0837-2020 | 01-27-2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01 Package NDCs: 62037-725-01; 62037-734-01; 62037-726-01; 62037-727-01 | CGMP deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / 17,436 bottles | Class II | Terminated |
| D-0836-2020 | 01-27-2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01 Package NDCs: 62037-725-01; 62037-734-01; 62037-726-01; 62037-727-01 | CGMP deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / | Class II | Terminated |
| D-0830-2020 | 01-27-2020 | Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01 | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / 22,868 bottles | Class II | Terminated |
| D-0831-2020 | 01-27-2020 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01 | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / 69,012 bottles | Class II | Terminated |
| D-0828-2020 | 01-24-2020 | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90. Package NDCs: 67877-445-30; 67877-445-90; 67877-445-05; 67877-445-10; 67877-446-30; 67877-446-90; 67877-446-05; 67877-446-10; 67877-446-33; 67877-446-84; 67877-446-74; 67877-446-38; 67877-447-30; 67877-447-90; 67877-447-05; 67877-447-10 | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. | Ascend Laboratories LLC / 192 Bottles | Class II | Terminated |
| D-1050-2020 | 01-24-2020 | Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. | Breckenridge Pharmaceutical, Inc / 11,250 bottles | Class II | Terminated |
| D-1051-2020 | 01-24-2020 | Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. | Breckenridge Pharmaceutical, Inc / 11, 250 bottles | Class II | Terminated |
| D-0838-2020 | 01-24-2020 | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09 Package NDCs: 33342-176-09; 33342-176-11; 33342-176-57; 33342-176-44; 33342-176-12; 33342-177-09; 33342-177-11; 33342-177-57; 33342-177-44; 33342-177-12 | Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. | Macleods Pharma Usa Inc / 4694 30x60-count bottles | Class III | Terminated |
| D-0827-2020 | 01-22-2020 | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30. Package NDCs: 67877-578-14; 67877-578-30; 67877-578-01; 67877-578-05; 67877-576-14; 67877-576-30; 67877-576-01; 67877-576-05; 67877-577-14; 67877-577-30; 67877-577-01; 67877-577-05; 67877-643-14; 67877-643-30; 67877-643-01; 67877-643-05; 67877-644-14; 67877-644-30; 67877-644-01; 67877-644-05; 67877-436-14; 67877-436-30; 67877-436-01; 67877-436-05; 67877-437-14; 67877-437-30; 67877-437-01; 67877-437-05; 67877-438-14; 67877-438-30; 67877-438-01; 67877-438-05 | Failed Dissolution Specifications: low out of specification results for dissolution testing. | Ascend Laboratories LLC / 4728 bottles | Class III | Terminated |
| D-0823-2020 | 01-20-2020 | Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10 Package NDCs: 33342-110-07; 33342-110-10; 33342-110-15; 33342-110-12; 33342-110-39; 33342-110-44; 33342-111-07; 33342-111-10; 33342-111-15; 33342-111-12; 33342-111-39; 33342-111-44 | Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product | Macleods Pharma Usa Inc / 10680 units | Class III | Terminated |
| D-0822-2020 | 01-16-2020 | Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11 | Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing). | Shandex Personal Care Manufacturing Inc. / 20448 cartons | Class II | Terminated |
| D-0947-2020 | 01-15-2020 | Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0989-2020 | 01-15-2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0982-2020 | 01-15-2020 | Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0946-2020 | 01-15-2020 | Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0940-2020 | 01-15-2020 | AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0943-2020 | 01-15-2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0965-2020 | 01-15-2020 | Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0991-2020 | 01-15-2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0935-2020 | 01-15-2020 | Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0956-2020 | 01-15-2020 | Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0966-2020 | 01-15-2020 | Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0978-2020 | 01-15-2020 | Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0970-2020 | 01-15-2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0639-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0994-2020 | 01-15-2020 | Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0959-2020 | 01-15-2020 | Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0955-2020 | 01-15-2020 | Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0985-2020 | 01-15-2020 | Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0958-2020 | 01-15-2020 | Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0948-2020 | 01-15-2020 | Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0976-2020 | 01-15-2020 | Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0975-2020 | 01-15-2020 | MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0934-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0952-2020 | 01-15-2020 | Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0977-2020 | 01-15-2020 | Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0979-2020 | 01-15-2020 | Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0933-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0987-2020 | 01-15-2020 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0937-2020 | 01-15-2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0950-2020 | 01-15-2020 | Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0961-2020 | 01-15-2020 | Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0969-2020 | 01-15-2020 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0624-1 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0964-2020 | 01-15-2020 | Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class III | Terminated |
| D-0967-2020 | 01-15-2020 | Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
| D-0981-2020 | 01-15-2020 | Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3 | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / N/A | Class II | Terminated |
