D-1020-2020 Class II Terminated
FDA drug recall D-1020-2020 was initiated by Perrigo Company PLC on October 23, 2019 and is designated Class II. Reason for recall: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. The recall status is terminated (terminated November 6, 2020).
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, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, 9JE2676