Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because testing detected the presence of the NDMA impurity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks such as carcinogenic impurities.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Glenmark Ranitidine Tablets USP 150 mg, 500-count bottles (NDC 68462-248-05). The recall involves 1,712,632 bottles distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. NDMA is a potential carcinogen that is strictly regulated in pharmaceutical products.
Consumers who have purchased these specific bottles should stop using the medication and contact their healthcare provider for guidance on alternative treatments. The affected lot codes are listed in the official FDA recall notice D-0644-2020.
The recalled product
- Product
- Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,712,632
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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