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, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09 |
| 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-1023-2020 |
| 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 ↗