D-0182-2020 Class II
FDA drug recall D-0182-2020 was initiated by Dr. Reddy's Laboratories, Inc. on October 1, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- October 1, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Code Information
Batch Numbers: All lots within expiry.