- Products Recalled
Recalled Medication: ACETIC ACID 2% EAR SOLUTION
Recalled Medication: CICLOPIROX 8% SOLUTION
Recalled Medication: FLUTICASONE PROP 50 MCG SPRAY
Recalled Medication: GUAIATUSSIN AC LIQUID
Recalled Medication: HYDROCORTISONE-ACETIC ACID SOLUTION
Recalled Medication: LACTULOSE 10 GM/15 ML SOLUTION
Recalled Medication: LIDOCAINE 2% VISCOUS SOLUTION
Recalled Medication: LIDOCAINE-PRILOCAINE CREAM
Recalled Medication: PILOCARPINE 1% EYE DROPS
Recalled Medication: PROMETHAZINE 6.25 MG/5 ML SOLUTION
Recalled Medication: PROMETHAZINE-CODEINE SYRUP
Manufacturer: Akorn Operating Company LLC
Recall Date: April 26, 2023
Reason: As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated.
FDA Notice - Recalled Medication: IDArubicin Hydrochloride Injection USP 5 mg/5 mL
Manufacturer: Teva Pharmaceuticals
Recall Date: 03/29/2022
Reason: Potential Particulate Matter (silica and iron oxide)
FDA Notice
- 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 2023-2024 – updated August 2023
- Alliance Covered Opioid List – updated May 2024
- Adult Vaccines Covered under Outpatient Pharmacy Benefit – updated October 2018
Fraud Waste and Abuse
- Report potential Fraud, Waste & Abuse cases
Pain Management
- Please see Alliance Pain Management
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