- Contact Us
- News and Events
- Investor Relations
- Locations and Facilities
- Careers
- About Our Site
- Accessibility Statement
- Privacy Policy
- Terms and Conditions
- For Employers and Medical Plan Providers
- For Pharmacists and Medical Professionals
- Drug Lists
- Drug Safety Alerts
- Emergency Response
- Mail Service Numbers, Forms and Information
- Specialty Pharmacy Services, Information and Forms
- Electronic Prior Authorization Information
- Clinical Drug Information
- Clinical Programs and Health Management
- Clinical Publications
- FAQs For Pharmacists and Pharmacy Staff
- Pharmacy Help Desk
- FAQs For Prescribers and Office Staff
- Contact Us | Health Professionals Only
Drug Safety Alerts
Ranitidine 150 mg/10 mL Syrup Consumer-Recall
11/08/2019
On November 8, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of Ranitidine Syrup 150 mg/10 mL manufactured by Lannett Company, Inc. and distributed by American Health Packaging.This recall was issued due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA for Ranitidine Hydrochloride Syrup (Ranitidine Oral Solution, USP). Lannett was notified by FDA of the potential presence of NDMA on September 17, 2019 and immediately commenced testing of the Active Pharmaceutical Ingredient (API) and drug product. The analysis confirmed the presence of NDMA.
A complete list of the affected products and lot numbers is provided here:
Risk Statement: NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables.
The product is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall was previously issued on November 1, 2019 by American Health Packaging to the retail-level.
CVS Caremark Response:
Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.
For more information about this recall, please contact American Health Packaging 1-800-707-4621 or visit www.americanhealthpackaging.com/recalls.
You may also contact the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.