D-1028-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- October 23, 2019
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE2161, 8KE2565, 8LE2261, 8ME2548, 9AE2658, 9BE3018, 9CE3861, 9DE3244, 9FE2820, 9FE3373, 9GE3094, 9HE3449, 9JE2665