D-1021-2020 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, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71
Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Distribution Pattern
Nationwide USA
Code Information
Lots: 8AE1744, 8BE1369, 8CE1377, 8CE1378, 8DE1103, 8DE1531, 8EE1700, 8FV0829, 8DE1722, 8EE1317, 8FE1635, 8GE1921, 8HE1342, 8KE2503R, 8JE2154, 8KE2503, 8LE2198, 8LE2597, 9AE2499, 9BE2862, 9BE2863, 9CE3723, 9DE2890, 9DE2891, 9EE2812, 9FE3187, 9GE2885, 9HE3435, 9JE2656