D-0175-2020 Class II
FDA drug recall D-0175-2020 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
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) 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.