Drug product

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02

D-1019-2020

October 23, 2019

Class II

Product summary

Firm: Perrigo Company PLC
Event: Event 84127
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: drug-enforcement:D-1019-2020

Official wording

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Code information: Lots: 8FV1462, 8GV1289, 8BE1465, 8CE1616, 8DE1277, 8DE1580, 8DE1766, 8FE1348, 8GE1527, 8GE1733, 8GE1735, 8HE1466, 8HE1590, 8JE2232, 8KE2676, 8LE2283, 8LE2284, 8LE2345, 8ME2640, 9AE2663, 9AE2863, 9AE2864, 9BE3158, 9CE3773, 9CE3774, 9CE3879, 9EE2499, 9EE2635, 9EE2904, 9FE2821, 9FE2953, 9FE3369, 9GE2653, 9GE2905, 9GE3077, 9GE3115, 9HE3546, 9HE3559, 9JE2593

Distribution pattern: Nationwide USA

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

impurity N-nitrosodimethylamine
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviation