Recall: D-0181-2020
Class II - Potentially Harmful
Class IIClassification
2019-10-01Initiated
CompletedStatus
Dr. Reddy's Laboratories, Inc.Firm
Product
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.