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, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62 |
| 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-1018-2020 |
| 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 ↗