Glenmark Pharmaceutical is recalling all unexpired lots of Ranitidine tablets.
The product may be contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.
Glenmark has not received any reports of adverse events to date.
The following products, used for treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease, are being recalled:
| NDC | Description | Expiration Date Range |
|---|---|---|
| 684620-248-60; 684620-248-01 and 684620-248-05 | Ranitidine Tablets, USP 150mg | 12/2019 – 5/2022 |
| 684620-249-30; 684620-249-01 and 684620-249-20 | Ranitidine Tablets, USP 300 mg | 12/2019 – 6/2022 |
The 150 mg products product are packaged in bottle packs of 60’s, 100’s and 500’s; the 300 mg products are packaged in bottle packs of 30’s, 100’s and 250’s.
What to do
Customers who purchased the recalled products should immediately discontinue use and consult with their physician or healthcare provider about treatment options.
Consumers may call Qualanex at (888) 504-2012, Monday – Friday, 9:00 am – 5:00 pm (EST) to arrange for product return.
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