- CHANTIX
Recalled Medication: Chantix, Varenicline tablets
Manufacturer: Pfizer
Recall Date: 09/16/2021
Reason: N-nitroso-varenicline above acceptable daily intake level
FDA Notice - CHANTIX® (Varenicline) Tablets
Recalled Medication: Chantix
Manufacturer: Pfizer
Recall Date: 07/16/2021
Reason: N-Nitroso Varenicline content above ADI level
FDA Notice - Recalled Medication: Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz
Manufacturer: Sunstar Americas, Inc.
Recall Date: 12/28/2020
Reason: Potential contamination with Burkholderia lata
FDA Notice - Recalled Medication: Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg
Manufacturer: Marksans Pharma Limited
Recall Date: 10/05/2020
Reason: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Notice - Recalled Medication: Albuterol Sulfate Inhalation Aerosol
Manufacturer: Catalent Pharma Solutions for Perrigo Pharmaceutical Company
Recall Date: 09/21/2020
Reason: Due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine.
FDA Notice - DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL
Manufacturer: Ferring Pharmaceuticals US
Recall Date: 08/05/2020
Reason: These products are being recalled due to superpotency or amounts of desmopressin higher than specified.
FDA Notice - Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg
Manufacturer: Lupin Pharmaceuticals, Inc.
Recall Date: 07/08/2020
Reason: Due to the detection of N-Nitrosodimethylamine (NDMA).
FDA Notice - Metformin Hydrochloride Extended-Release Tablets USP, 750mg
Manufacturer: Granules Pharmaceuticals, Inc.
Recall Date: 07/03/2020
Reason: Due to the detection of N-Nitrosodimethylamine (NDMA).
FDA Notice - Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Manufacturer: Amneal Pharmaceuticals LLC
Recall Date: 05/29/2020
Reason: Due to detection of N-Nitrosodimethylamine (NDMA).
FDA Notice - Metformin Hydrochloride Extended-Release Tablets, USP 500mg
Manufacturer: Apotex Corp.
Recall Date: 05/27/2020
Reason: Due to detection of N-Nitrosodimethylamine (NDMA).
FDA Notice - All Ranitidine Products (Zantac)
Manufacturer: All
Recall Date: 04/01/2020
Reason: Ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) which is a probable human carcinogen (a substance that could cause cancer).
FDA Notice
- Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL
Manufacturer: Amneal Pharmaceuticals, LLC
Recall Date: 11/08/2019
Reason: Due to potential N-Nitrosodimethylamine (NDMA) amounts being above levels established by the FDA.
FDA Notice - Ranitidine Tablets 150mg, Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg and Ranitidine Syrup 15 mg/mLRanitidine Tablets, Capsules, and Syrup
Manufacturer: Aurobindo Pharma USA, Inc.
Recall Date: 11/06/2019
Reason: Due to the detection of Nitrosodimethylamine (NDMA) impurity.
FDA Notice - Ranitidine Syrup (Oral Solution, USP), 15 mg/mL
Manufacturer: Lannett Company, Inc.
Recall Date: 10/25/2019
Reason: Due to levels of N-Nitrosodimethylamine (NDMA) being above the levels recently established by the FDA.
FDA Notice - Ranitidine Tablets & Capsules
Manufacturer: Dr. Reddy’s Laboratories Ltd.
Recall Date: 10/23/2019
Reason: Contamination with N-Nitrosodimethylamine (NDMA) above the levels established by the FDA.
FDA Notice - Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg
Recall Date: 06/26/2019
Manufacturer: Macleods Pharmaceuticals, Ltd.
Reason: Detection of trace amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable daily intake levels released by the FDA.
FDA Notice - Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg
Recall Date: 02/22/2019
Manufacturer: Macleods Pharmaceuticals, Ltd.
Reason: Detection of trace amounts of an unexpected impurity (NDEA) above the interim acceptable daily intake levels released by the FDA.
FDA Notice - Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
Recall Date: 01/22/19
Manufacturer: Torrent Pharmaceuticals Limited
Reason: Detection of trace amounts of an N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
FDA Notice - Irbesartan and Irbesartan HCTZ Tablets
Recall Date: 01/18/2019
Manufacturer: Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
Reason: Detection of trace amount of N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
FDA Notice - Valsartan and Valsartan-HCTZ Tablets, USP
Recall Date: 07/18/2018
Manufacturers: Prinston Pharmaceuticals, and TEVA Pharmaceuticals.
Reason: It has been found that the recalled products for impurity detected. This may cause unexpected health risks.
FDA Notice – Prinston Pharmaceuticals
FDA Notice – TEVA Pharmaceuticals
- Provider Alert: New Boxed Warning for Lunesta (eszopiclone), Sonata (zaleplon), Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem) (05/23/19)
- Provider Alert: Legacy Pharmaceutical Packaging, LLC – Losartan Potassium Tablets Medication Recall (03/15/19)
- Provider Alert: EpiPen Use (08/21/2018)
- Provider Alert: Levothyroxine and Liothyronine (Thyroid Tablets, USP) Medication Recall (08/09/2018)
- Provider Alert: Rugby Diocto Medication Recall (8/2017)
- Provider Alert: Hospira Issues a Voluntary Nationwide Recall (6/15/17)
- Provider Alert: All Topical Products made by Phillips Company Medication Recall (6/9/2017)
- Provider Alert: All Lots of Diocto Liquid, 50 mg/5 mL for NCD 0536-0590-85 Medication Recall (07/15/2016)
- Provider Alert: All Medications Compounded by Reliable Drug Medication Recall (3/25/2016)
- Provider Alert: Amikacin Sulfate Injection 1 gram per 4mL Medication Recall (03/09/2016)
- Provider Alert: Fluconzaole Injection 200mg per 100mL Medication Recall (03/01/2016)
- Provider Alert: Acetaminophen Tablets, 500mg Medication Recall (10/14/2015)
- Provider Alert: Auvi-Q Medication Recall (10/28/2015)
Formulary
- Formulary Management Process
- Comprehensive Medication Formulary
- Formulary Contraceptives – updated August 2021
- Smoking Cessation Medications – updated June 2020
- Group Care Prior Authorization form
- Alliance Covered Flu Vaccine List 2021 – updated August 2021
- Alliance Covered Opioids List – updated September 2021
- Adult Vaccines Covered under Outpatient Pharmacy Benefit – updated October 2018
Fraud Waste and Abuse
- Report potential Fraud, Waste & Abuse cases
Pain Management
- Alliance Covered Opioids List– updated September 2021
Specialty
- The Alliance has expanded PerformSpecialty services to cover hepatitis C.
- Treatment Policy for the Management of Chronic Hepatitis C
Safety Resources
We have gathered information from press releases and other public notices about certain recalls of Food and Drug Administration (FDA)-regulated products to share with you.
Medication Safety Bulletins
If your patient is taking any of the products below:
- Please have them consider changing to a different medication for their condition.
- Remind them to return the recalled medication to their pharmacy.
Below are recent nationwide medication recalls and notices:
Medication Safety Communications - Medi-Cal
- DUR: What’s New and Ongoing Projects
- Right Care Initiative – California Statewide Goals using HEDIS® measures (April 2019)
- CDC – Advisory Committee on Immunization Practices (ACIP): Recommendations (March 2019)
- CDPH – Prevention Forward (March 2019)
- Standards of Medical Care in Diabetes – 2022 Abridged for Primary Care Providers (2022)
- 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease (2019)
- Medicaid & CHIP in California – Adult Core Set Reporting (2019)
- Health Affairs: One In Five Fewer Heart Attacks: Impact, Savings, And Sustainability In San Diego County (September 2018)
- CDC – Implementing a Quality Improvement Collaborative to Improve Hypertension Control
- CDC – Adult Vaccination Resources for Provider Practices (May 2016)
- AHA Journals – Hypertension Pharmacological Treatment in Adults
- DHCS – Medi-Cal Medication Safety
- Food & Drug Administration (FDA) – Medication Safety Materials