Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
| Distributed by / for | Perrigo Company PLC |
| Full product label | 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 |
| Recalling firm | Perrigo Company PLC |
| Distribution | Nationwide USA |
| Recall initiated | 2019-10-23 |
| Report date | 2020-03-25 |
| Recall completed | 2020-11-06 |
| Recall number | D-1021-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Allegan MI United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗