Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because an NDMA impurity was detected. The product was distributed to major distributors throughout the United States.
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. Per the rubric, FDA Class II recalls involving significant health risks like NDMA impurities are categorized as Severe (Score 4), as they are not Class I but involve serious potential harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.
The affected product includes all lots within the expiry date. The medication was distributed to major distributors throughout the United States, who may have further distributed the product to retail locations.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as FDA Class II.
The recalled product
- Product
- Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Numbers: All lots within expiry.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Dr. Reddy's Laboratories, Inc. 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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