Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of 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, and the presence of NDMA impurity in a drug product is a significant health hazard that meets the criteria for a Severe rating.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, sold as Kroger OTC. The recall covers 24-count bottles (NDC 30142-505-34) and 50-count bottles (NDC 30142-505-50). The product was distributed to major distributors throughout the United States, who may have further distributed it.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text indicates that all lots within expiry are affected.
Consumers should stop using the recalled product and consult their healthcare provider or pharmacist for guidance on alternative treatments or next steps.
The recalled product
- Product
- Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) 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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