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 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65 |
| 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-1012-2020 |
| 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 ↗