Recall: D-0180-2020
Class II - Potentially Harmful
Class IIClassification
2019-10-01Initiated
CompletedStatus
Dr. Reddy's Laboratories, Inc.Firm
Product
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
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.