Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
| Brand name | EQUATE PAIN AND FEVER |
| Generic name | ACETAMINOPHEN |
| Active ingredient(s) | ACETAMINOPHEN |
| Distributed by / for | Wal-Mart Stores, Inc., Bentonville, AR 72716 |
| NDC | 49035-946-16 |
| Full product label | Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16 |
| Recalling firm | Perrigo Company PLC |
| Distribution | Nationwide in the USA |
| Quantity | 68,688 bottles |
| Recall initiated | 2021-10-26 |
| Report date | 2022-03-02 |
| Recall completed | 2023-09-29 |
| Recall number | D-0598-2022 |
| 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 ↗