Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected 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, which corresponds to a Severe rating under the rubric, particularly given the presence of the NDMA impurity in a pharmaceutical product.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 150 mg, in 95-count and 220-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 43598-808-62 and NDC 43598-808-65. The source text indicates that all lots within the expiry date are included in this recall. The product was distributed to major distributors throughout the United States, who may have further distributed the product to other locations.
Consumers who have purchased these specific bottles of Ranitidine Tablets should stop using them and contact their pharmacist or Dr. Reddy's Laboratories for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Oral Solid Dosage
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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