Recall: D-0168-2020
Class II - Potentially Harmful
Class IIClassification
2019-10-01Initiated
CompletedStatus
Dr. Reddy's Laboratories, Inc.Firm
Product
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
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.