Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | January 3, 2024 | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only,… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Donepezil Hydrochloride Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S.… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Estradiol ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Spiriva SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class III | January 3, 2024 | ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler… | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification | GlaxoSmithKline LLC | Terminated |
| Class II | January 3, 2024 | Amoxicillin AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Amoxicillin AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons,… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Aripiprazole Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Albuterol Sulfate ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations,… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | ASMANEX Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories,… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Propranolol Hydrochloride Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Jardiance Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by:… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Hydralazine Hydrochloride HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only,… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Terconazole Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Dicyclomine Hydrochloride Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For:… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only,… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Wixela Inhub Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | January 3, 2024 | Allopurinol ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By:… | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE | Terminated |
| Class II | December 27, 2023 | NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For… | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc | Ongoing |
| Class II | December 27, 2023 | NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For… | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc | Ongoing |
| Class I | December 27, 2023 | THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card,… | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found… | Noah's Wholesale LLC | Ongoing |
| Class II | December 27, 2023 | NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For… | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc | Ongoing |
| Class II | December 27, 2023 | NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For… | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc | Ongoing |
| Class II | December 27, 2023 | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal… | CGMP Deviations: Stability data does not support expiry date. | Private Label Partners, Inc. | Ongoing |
| Class I | December 27, 2023 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans… | Chemical contamination: Presence of benzene | Blistex Inc | Terminated |
| Class I | December 27, 2023 | Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups… | Failed Content Uniformity Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class I | December 27, 2023 | TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz… | Chemical Contamination; presence of benzene. | Insight Pharmaceuticals Corporation | Completed |
| Class II | December 20, 2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin… | Failed Dissolution Specifications | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | December 20, 2023 | Liothyronine Sodium Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun… | Failed Impurities/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class III | December 20, 2023 | Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried… | Failed Dissolution Specifications | Siegfried Barbera, SL | Completed |
| Class II | December 13, 2023 | KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension,… | Failed Impurities/Degradation Specifications | KINDER FARMS LLC | Ongoing |
| Class I | December 13, 2023 | Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support… | MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide | SUGARMDS LLC | Ongoing |
| Class II | December 13, 2023 | KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension,… | Failed Impurities/Degradation Specifications | KINDER FARMS LLC | Ongoing |
| Class II | December 13, 2023 | Trospium Chloride Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only,… | Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules | Padagis US LLC | Ongoing |
| Class III | December 13, 2023 | LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel),… | Product Mix-up: Incorrect Product Formulation | Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop | Terminated |
| Class III | December 13, 2023 | bupropion hydrochloride buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle,… | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | December 13, 2023 | ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500… | STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon… | STAQ Pharma, Inc. | Completed |
| Class II | December 13, 2023 | ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per… | Lack of assurance of sterility. | Wells Pharma of Houston LLC | Completed |
| Class II | December 13, 2023 | Ondansetron Hydrochloride Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured… | Failed pH Specifications | Baxter Healthcare Corporation | Completed |
| Class I | December 13, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx… | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals | Novartis Pharmaceuticals Corporation | Ongoing |
| Class II | December 6, 2023 | Paroxetine PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b)… | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification… | Golden State Medical Supply Inc. | Terminated |
| Class I | December 6, 2023 | VITRAKVI VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for… | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum… | Bayer Healthcare Pharmaceuticals Inc. | Terminated |
| Class III | December 6, 2023 | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL),… | Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe… | Fagron Compounding Services | Ongoing |
| Class I | December 6, 2023 | Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico,… | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be | Ongoing |
| Class I | December 6, 2023 | Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles,… | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be | Ongoing |
| Class I | December 6, 2023 | Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga,… | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be | Ongoing |
| Class III | December 6, 2023 | Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL)… | Failed Excipient Specifications: high content of ethylene glycol (EG) | VistaPharm LLC | Terminated |
| Class II | December 6, 2023 | Paroxetine Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#:… | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose… | Apotex Corp. | Ongoing |
| Class II | December 6, 2023 | Paroxetine Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle,… | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose… | Apotex Corp. | Ongoing |
| Class III | December 6, 2023 | testosterone Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per… | OOS for viscosity | Teva Pharmaceuticals USA, Inc | Terminated |
| Class II | December 6, 2023 | Paroxetine Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#:… | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose… | Apotex Corp. | Ongoing |
| Class II | December 6, 2023 | Paroxetine Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle,… | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose… | Apotex Corp. | Ongoing |
| Class II | December 6, 2023 | Indomethacin Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark… | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 6, 2023 | Paroxetine PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90;… | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification… | Golden State Medical Supply Inc. | Terminated |
| Class II | December 6, 2023 | Paroxetine PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b)… | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification… | Golden State Medical Supply Inc. | Terminated |
| Class II | December 6, 2023 | Naproxen Sodium Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark… | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | November 29, 2023 | ELCYS ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single… | Presence of Particulate Matter: Silicone | Exela Pharma Sciences LLC | Ongoing |
| Class I | November 29, 2023 | LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | Cardinal Health Inc. | Ongoing |
| Class III | November 29, 2023 | Esomeprazole Magnesium Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count… | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities… | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class I | November 29, 2023 | Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class I | November 29, 2023 | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose… | Presence of Particulate Matter: Silicone | Exela Pharma Sciences LLC | Ongoing |
| Class I | November 29, 2023 | Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist.… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class I | November 29, 2023 | LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL)… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | Cardinal Health Inc. | Ongoing |
| Class II | November 29, 2023 | Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented… | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified… | Integrity Bio-Chemicals LLC | Terminated |
| Class I | November 29, 2023 | LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%,… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | Cardinal Health Inc. | Ongoing |
| Class II | November 29, 2023 | Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented… | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified… | Integrity Bio-Chemicals LLC | Terminated |
| Class III | November 29, 2023 | Buspirone Hydrochloride Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC… | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | NCS Healthcare of Kentucky Inc | Terminated |
| Class II | November 29, 2023 | Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented… | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified… | Integrity Bio-Chemicals LLC | Terminated |
| Class I | November 29, 2023 | LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | Cardinal Health Inc. | Ongoing |
| Class I | November 29, 2023 | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | Cardinal Health Inc. | Ongoing |
| Class I | November 29, 2023 | SODIUM BICARBONATE 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose… | Presence of Particulate Matter: Silicone | Exela Pharma Sciences LLC | Ongoing |
| Class I | November 29, 2023 | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL)… | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the… | Cardinal Health Inc. | Ongoing |
| Class III | November 29, 2023 | Buspirone Hydrochloride Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b)… | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | NCS Healthcare of Kentucky Inc | Terminated |
| Class II | November 29, 2023 | Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL… | Failed Viscosity Specifications: Out-of-specification test results for viscosity | ITF PHARMA INC | Terminated |
| Class II | November 22, 2023 | Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9 | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified… | Omega & Delta Co., Inc. | Ongoing |
| Class II | November 22, 2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle,… | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified… | Omega & Delta Co., Inc. | Ongoing |
| Class II | November 22, 2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118… | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified… | Omega & Delta Co., Inc. | Ongoing |
| Class II | November 22, 2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E;… | cGMP Deviations | Family Medical Supply Inc | Terminated |
| Class II | November 15, 2023 | Deferasirox Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured… | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class III | November 15, 2023 | V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive… | Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula… | Grato Holdings, Inc. | Terminated |
| Class II | November 15, 2023 | Montelukast Sodium Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr.… | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | November 15, 2023 | oxybutynin Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only,… | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long… | Zydus Pharmaceuticals (USA) Inc | Completed |
| Class II | November 15, 2023 | Ranolazine Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured… | Failed Dissolution Specifications: Out of specification for dissolution. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | November 15, 2023 | oxybutynin Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only,… | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long… | Zydus Pharmaceuticals (USA) Inc | Completed |
| Class II | November 15, 2023 | oxybutynin Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only,… | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long… | Zydus Pharmaceuticals (USA) Inc | Completed |
| Class II | November 15, 2023 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient:… | CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it… | MEDLINE INDUSTRIES, LP - Northfield | Terminated |
| Class I | November 15, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of… | Presence of Particulate Matter: identified as glass. | Pfizer Inc. | Terminated |
| Class III | November 15, 2023 | Mycophenolate Mofetil Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured… | Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. | VistaPharm LLC | Terminated |
| Class III | November 15, 2023 | OXAYDO Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed… | Sub-potent Drug: Lower potency than labeled. | Zyla Life Sciences US Inc. | Ongoing |
| Class II | November 15, 2023 | Buprenorphine Hydrochloride Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only,… | Crystallization; identified as Buprenorphine free base | PAR Sterile Products LLC | Terminated |
| Class III | November 15, 2023 | Synthroid Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only… | Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that… | AbbVie Inc. | Ongoing |
| Class II | November 15, 2023 | Extended Phenytoin Sodium Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal… | Failed Dissolution Specifications | Amneal Pharmaceuticals of New York, LLC | Terminated |
| Class I | November 15, 2023 | 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe,… | Presence of Particulate Matter: identified as glass. | Pfizer Inc. | Terminated |
| Class III | November 15, 2023 | hydrocortisone and acetic acid Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only,… | Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and… | Taro Pharmaceuticals Inc. | Terminated |
| Class I | November 15, 2023 | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe,… | Presence of Particulate Matter: identified as glass. | Pfizer Inc. | Terminated |
| Class III | November 8, 2023 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4… | Subpotent Drug | Edenbridge Pharmaceuticals, LLC | Terminated |
| Class II | November 8, 2023 | Liothyronine Sodium Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun… | Failed Impurities/Degradation Specifications. | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | November 8, 2023 | Liothyronine Sodium Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun… | Failed Impurities/Degradation Specifications. | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | November 8, 2023 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled… | Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic… | Padagis US LLC | Ongoing |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class II | November 8, 2023 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle… | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Safecor Health, LLC | Terminated |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class III | November 8, 2023 | Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle,… | Failed Impurities/Degradation Specifications | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class II | November 8, 2023 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets,… | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed |
| Class II | November 1, 2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature | Terminated |
| Class I | November 1, 2023 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature | Terminated |
| Class III | November 1, 2023 | VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters… | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class II | November 1, 2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence… | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature | Terminated |
| Class III | November 1, 2023 | VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters… | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class III | November 1, 2023 | Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per… | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class III | November 1, 2023 | Methotrexate Sodium Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only,… | Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating… | West-Ward Columbus Inc | Ongoing |
| Class II | October 25, 2023 | Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only,… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only,… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores. | CGMP Deviations: OTC products were stored outside of labeled temperature requirements. | Dollar Tree Distribution, Inc. | Ongoing |
| Class II | October 25, 2023 | Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class I | October 25, 2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl.… | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Church & Dwight Inc | Ongoing |
| Class II | October 25, 2023 | Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution,… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class II | October 25, 2023 | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use… | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC | Terminated |
| Class III | October 25, 2023 | bupropion hydrochloride Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx… | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class III | October 25, 2023 | MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic… | Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. | Imprimis NJOF, LLC | Terminated |
| Class I | October 25, 2023 | betaxolol hydrochloride Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown,… | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. | KVK-Tech, Inc. | Terminated |
| Class II | October 25, 2023 | DOXIL Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL),… | CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation… | Baxter Healthcare Corporation | Terminated |
| Class I | October 25, 2023 | Sucralfate Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case),… | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | VistaPharm LLC | Terminated |
| Class I | October 18, 2023 | BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and… | Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with… | Scynexis, Inc. | Completed |
| Class II | October 11, 2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's… | CGMP Deviations | Dr. Berne's Whole Health Products | Ongoing |
| Class I | October 11, 2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's… | Non-Sterility | Dr. Berne's Whole Health Products | Ongoing |
| Class II | October 11, 2023 | Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by:… | CGMP Deviations | Dr. Berne's Whole Health Products | Ongoing |
| Class II | October 11, 2023 | Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's… | CGMP Deviations | Dr. Berne's Whole Health Products | Ongoing |
| Class II | October 11, 2023 | Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's… | CGMP Deviations | Dr. Berne's Whole Health Products | Ongoing |
| Class II | October 11, 2023 | HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | oxybutynin Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01)… | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc | Terminated |
| Class II | October 11, 2023 | succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | Triamcinolone Acetonide Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL… | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass… | Eugia US LLC | Ongoing |
| Class II | October 11, 2023 | fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc.,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class III | October 11, 2023 | Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection… | Subpotent: Failing Test Results for Epinephrine | Imprimis NJOF, LLC | Terminated |
| Class II | October 11, 2023 | fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only,… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class II | October 11, 2023 | HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central… | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc | Terminated |
| Class III | October 11, 2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only,… | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at… | Amerisource Health Services LLC | Terminated |
| Class III | October 4, 2023 | ELIGARD Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx… | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. | Tolmar, Inc. | Terminated |
| Class II | October 4, 2023 | Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose… | Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). | Sofie Co dba Sofie | Terminated |
| Class III | October 4, 2023 | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count… | Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging. | RB Health (US) LLC | Terminated |
| Class II | September 27, 2023 | TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF… | Subpotent Drug: Product does not contain SPF that is declared on the label. | HUMANRACE | Ongoing |
| Class II | September 27, 2023 | Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged… | Subpotent Drug: Product does not contain SPF that is declared on the label. | HUMANRACE | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc.… | Failed dissolution specifications - results obtained were below spec average. | Aurobindo Pharma USA Inc. | Terminated |
| Class II | September 27, 2023 | TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL),… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 27, 2023 | octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class III | September 27, 2023 | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%,… | Incorrect/Undeclared Excipients. | Vi-Jon, LLC | Terminated |
| Class II | September 27, 2023 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot… | CareFusion 213, LLC | Completed |
| Class I | September 27, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx… | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. | Novartis Pharmaceuticals Corp. | Ongoing |
| Class III | September 27, 2023 | CEQUA Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10… | Subpotent: Out of Specification result observed for low assay | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | September 27, 2023 | MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ… | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES | Ongoing |
| Class II | September 20, 2023 | Pantoprazole Sodium Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01… | Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. | BE PHARMACEUTICALS AG | Terminated |
| Class II | September 20, 2023 | Sucralfate Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx… | Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results | VistaPharm LLC | Terminated |
| Class I | September 20, 2023 | WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY… | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient… | Hua Da Trading, Inc. dba Wefun Inc. | Terminated |
| Class II | September 13, 2023 | Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by:… | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and… | Marlex Pharmaceuticals, Inc. | Terminated |
| Class I | September 13, 2023 | Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed… | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and… | Marlex Pharmaceuticals, Inc. | Terminated |
| Class II | September 13, 2023 | Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride… | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but… | AVKARE LLC | Terminated |
| Class III | September 13, 2023 | Milrinone Lactate Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per… | Failed Impurities/Degradation Specifications | Caplin Steriles Limited | Terminated |
| Class III | September 13, 2023 | Fosfomycin Tromethamine Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only,… | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at… | Ascend Laboratories, LLC | Terminated |
| Class II | September 13, 2023 | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1… | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental… | AVKARE LLC | Terminated |
| Class III | September 13, 2023 | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured… | Failed dissolution specifications: below specification results at stability 12-month | Esperion | Terminated |
| Class I | September 6, 2023 | Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp.… | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found… | APG SEVEN, INC | Ongoing |
| Class II | September 6, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume =… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume =… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class III | September 6, 2023 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by:… | Defective Container: slow leakage under the cap | Contract Pharmaceuticals Limited Canada | Terminated |
| Class II | September 6, 2023 | PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only,… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | September 6, 2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture… | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. | Terminated |