D-1022-2020 Class II Terminated
FDA drug recall D-1022-2020 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, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 8AE1752, 8BE1412, 8CE1437, 8CE1439, 8DE1141, 8DE1737, 8EE1318, 8FE1690, 8GE1928, 8HE1395, 8JE2155, 8KE2516, 8LE2253, 8LE2624, 9AE2522, 9BE2933, 9BE2934, 9CE3734, 9DE3070, 9EE2830, 9FE3266, 9GE2934