D-1027-2020 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, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202