D-0176-2020 Class II
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, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) 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.