nirvanaHealth is committed to the safety and health of our members. As a service to our members, clients, pharmacies and prescribers, nirvanaHealth monitors drug recalls, withdrawals, and safety alerts communicated by the U.S. Food and Drug Administration (FDA), drug companies, drug distributors, and regulatory agencies. nirvanaHealth monitors these alerts closely to ensure that the drugs dispensed are safe for our members. nirvanaHealth will notify members and prescribers affected by these alerts.
Drug companies and the FDA issue recalls to protect the public from defective or potentially harmful drugs. These drug recalls are classified in the following manner:
- Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
- Class II recalls are for products that might cause a temporary health problem or pose only a slight threat of a serious nature.
- Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA regulations.
The FDA may also issue safety alerts or drug withdrawals. In the event of a drug withdrawal, the drug will be removed from the drug formulary according to FDA guidance.
The alerts provided here include valuable information for your convenience.
| Product Name | Alert Type | Manufacturer | Date of Notice |
|---|---|---|---|
| Ukoniq™ (umbralisib) Tablets | Withdrawal Alert | TG Therapeutics | 6/1/2022 |
| SyrSpend SF Cherry | Recall Alert | Fagron Inc | 5/2/2022 |
| Compounded Drugs | Recall Alert | Drug Depot LLC | 4/26/2022 |
| IDArubicin hydrochloride injection | Recall Alert | Pfizer | 4/22/2022 |
| Insulin Glargine (insulin glargine-yfgn) | Recall Alert | Mylan Pharmaceuticals Inc | 4/12/2022 |
| Accupril® (quinapril HCl) tablets | Recall Alert | Teva Pharmaceuticals | 3/29/2022 |
| Symjepi® (epinephrine) injection | Recall Alert | Adamis Pharmaceutical Corporation | 3/22/2022 |
| Accuretic™ (quinapril HCl/hydrochlorothiazide) and Generic Tablets | Recall Alert | Pfizer | 3/22/2022 |
| Orphenadrine Citrate 100 mg Extended-Release Tablets | Recall Alert | Sandoz Inc | 3/22/2022 |
| Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD compounded injectables | Recall Alert | Olympia Pharmacy | 3/10/2022 |
| Polymyxin B for Injection | Recall Alert | AuroMedics Pharma LLC | 1/28/2022 |
| Semglee® (insulin glargine injection) | Recall Alert | Mylan Pharmaceuticals | 1/19/2022 |
| metformin hydrochloride ER tablets | Recall Alert | Viona Pharmaceuticals Inc | 1/12/2022 |
| lidocaine topical solution | Recall Alert | Teligent Pharma, Inc | 12/7/2021 |
| Veklury (remdesivir 100mg for injection) | Recall Alert | Gilead | 12/3/2021 |
| enoxaparin sodium injection | Recall Alert | Sandoz | 12/1/2021 |
| varenicline | Recall Alert | Pfizer | 9/16/2021 |
| Chantix (varenicline) | Recall Alert | Pfizer | 7/20/2021 |
| Chantix (varenicline) | Recall Alert | Pfizer | 7/2/2021 |
| metformin hydrochloride extended-release tablets | Recall Alert | Viona Pharmaceuticals Inc. | 6/11/2021 |
| Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® | Recall Alert | Novo Nordisk | 5/10/2021 |
| NP Thyroid® | Recall Alert | Acella Pharmaceuticals, LLC | 4/30/2021 |
| Monoclonal Antibody Bamlanivimab | Safety Alert | U.S. Food and Drug Administration (FDA) | 4/16/2021 |
| Guanfacine Extended-Release | Safety Alert | Apotex Corp | 3/31/2021 |
| Enoxaparin Sodium Injection, USP | Recall Alert | Apotex Corp | 2/2/2021 |
| Cisatracurium Besylate Injection | Recall Alert | Meitheal Pharmaceuticals, Inc. | 1/27/2021 |
| ketorolac tromethamine injection | Recall Alert | Fresenius Kabi USA, LLC | 1/8/2021 |
| metformin hydrochloride ER tablets | Recall Alert | Nostrum Laboratories, Inc. | 1/4/2021 |
| Paroex Chlorhexidine Gluconate Oral Rinse | Recall Alert | Precision Dose, Inc. | 12/31/2020 |
| Paroex® Chlorhexidine Gluconate Oral Rinse | Recall Alert | Sunstar Americas, Inc. (SAI) | 12/28/2020 |
| Anagrelide Capsules | Recall Alert | Torrent Pharmaceuticals Limited | 12/9/2020 |
| Sildenafil Tablets and Trazodone Tablets | Recall Alert | AvKARE, Pulaski, TN | 12/9/2020 |
| Dexmedetomidine Hydrochloride Injection | Recall Alert | Fresenius Kabi USA | 11/19/2020 |
| Chlorhexidine Gluconate Oral Rinse USP | Recall Alert | Lohxa, LLC | 11/9/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Nostrum Laboratories, Inc. | 11/3/2020 |
| metformin hydrochloride ER tablets | Recall Alert | Nostrum Laboratories, Inc. | 11/2/2020 |
| Paroex® (chlorhexidine gluconate) Oral Rinse USP | Recall Alert | Sunstar Americas, Inc. (SAI) | 10/27/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Marksans Pharma Limited | 10/05/2020 |
| Riomet ER™ | Recall Alert | Sun Pharmaceutical Industries, Inc. (Sun Pharma) | 9/23/2020 |
| Albuterol Inhaler | Recall Alert | The U.S. Food and Drug Administration (FDA) | 9/21/2020 |
| NP Thyroid® | Recall Alert | Acella Pharmaceuticals, LLC | 9/17/2020 |
| Nature-Throid® and WP Thyroid® | Recall Alert | RLC Labs, Inc. | 9/3/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Bayshore Pharmaceuticals, LLC | 8/20/2020 |
| Heparin Sodium Compounded Products | Recall Alert | SCA Pharmaceuticals (SCA) | 8/18/2020 |
| DDAVP®, desmopressin acetate and Stimate® Nasal Spray | Recall Alert | Ferring Pharmaceuticals U.S. | 8/5/2020 |
| Dexmedetomidine Hydrochloride Injection | Recall Alert | Fresenius Kabi USA | 7/22/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Lupin Pharmaceuticals Inc. | 7/8/2020 |
| Daptomycin for Injection | Recall Alert | Mylan | 7/7/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Granules Pharmaceuticals, Inc. | 7/3/2020 |
| Children’s Robitussin and Children’s Dimetapp | Recall Alert | GSK Consumer Healthcare | 6/18/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Teva Pharmaceuticals USA, Inc. | 6/2/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Marksans Pharma Limited | 6/2/2020 |
| Epinephrine Auto-Injector Devices | Safety Alert | Amneal and Impax epinephrine | 6/1/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Amneal Pharmaceuticals LLC | 5/29/2020 |
| Metformin Hydrochloride ER Tablets | Recall Alert | Apotex Corp | 5/27/2020 |
| NP Thyroid | Recall Alert | Acella Pharmaceuticals LLC | 5/22/2020 |
| Lactated Ringer’s Injection | Recall Alert | ICU Medical Inc | 5/8/2020 |
| Finasteride Plus 1.25mg | Recall Alert | MasterPharm LLC | 5/6/2020 |
| Chloroquine | Safety Alert | All Manufacturers | 4/24/2020 |
| Hydroxychloroquine | Safety Alert | All Manufacturers | 4/24/2020 |
| True Metrix Air Blood Glucose Meter | Recall Alert | Trividia Health Inc | 4/20/2020 |
| Ketorolac Injection | Recall Alert | Fresenius Kabi | 4/20/2020 |
| Ranitidine capsules | Withdrawal Alert | Strides Pharma | 4/17/2020 |
| Tetracycline capsules | Recall Alert | Avet Pharmaceutics Inc | 4/15/2020 |
| Nizatidine oral solution | Recall Alert | Amneal Pharmaceuticals LLC | 4/15/2020 |
| Limbrel | Recall Alert | Primus Pharmaceuticals | 4/13/2020 |
| Ranitidine syrup | Withdrawal Alert | Pharmaceutical Associates | 4/7/2020 |
| Ranitidine (Zantac) | Withdrawal Alert | All Manufacturers | 4/1/2020 |
| Phytonadione injectable | Recall Alert | Dr. Reddy Laboratories | 3/26/2020 |
| EpiPen and generics | Safety Alert | Pfizer and Mylan | 3/24/2020 |
| Ketorolac Injection | Recall Alert | Hikma Pharmaceuticals | 3/4/2020 |
| Montelukast (Singulair) | Safety Alert | All Manufacturers | 3/4/2020 |
| Phenytoin Oral Suspension | Recall Alert | Taro Pharmaceuticals | 2/20/2020 |
| Belviq and Belviq XR | Withdrawal Alert | Eisai | 2/13/2020 |
| Clozapine (Clozaril-Fazaclo and Versacloz) | Safety Alert | All Manufacturers | 1/28/2020 |
| Lamotrigine Tablets | Recall Alert | Taro Pharmaceuticals | 1/10/2020 |
| Nizatidine capsules | Recall Alert | Mylan | 1/8/2020 |
| Ranitidine capsules | Recall Alert | Appco Pharma | 1/7/2020 |
| Ranitidine tablets | Recall Alert | Denton Pharma Inc | 1/6/2020 |
