Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
Dr. Reddy's Laboratories is recalling specific bottles of Ranitidine Tablets 150 mg because an NDMA impurity was detected.
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 the presence of NDMA impurity in a drug product represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, in 24-count and 95-count bottles. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.
The affected products are identified by NDC 71713-203-02 (24 count) and NDC 71713-203-05 (95 count). The recall covers all lots within the expiry date. The product was distributed to major distributors throughout the United States, who may have further distributed the product to retail locations.
Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact Dr. Reddy's Laboratories for further instructions.
The recalled product
- Product
- Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
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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