Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity in the product.
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 and involves the detection of NDMA, a known carcinogenic impurity, which meets the criteria for a Severe rating.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling Glenmark Ranitidine Tablets USP 300 mg, 100-count bottles. The recall involves 1,309,536 bottles distributed nationwide.
The FDA identified the presence of the NDMA impurity in the product, which constitutes a Current Good Manufacturing Practice (CGMP) deviation. The agency has classified this recall as Class II.
Consumers should check their medication for the specific NDC 68462-249-01 and the lot codes listed in the recall notice. If the medication matches the recalled product, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,309,536
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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