January 29 2019 from FDA:
Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
| Lot No. | NDC | EXPIRATION | DESCRIPTION | COMPANY |
|---|---|---|---|---|
| 4718 | 59779-925-23 | 12/19 | CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle | CVS Pharmacy |
| 00717005A | 49035-125-24 | 02/19 | Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle | Wal-Mart Stores Inc. |
| 00717006A | 59779-925-24
(Labeled as: 50428-1252-4) | 02/19 | CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle | CVS Pharmacy |
| 00717009A (Previously announced) | 49035-125-23 | 02/19 | Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | Wal-Mart Stores Inc |
| 00717015A (Previously announced) | 49035-125-23 | 04/19 | Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | Wal-Mart Stores Inc |
| 00717024A (Previously announced) | 49035-125-23 | 08/19 | Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | Wal-Mart Stores Inc |
| 59779-925-23 | CVS Health: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | CVS Pharmacy | ||
| 55319-250-23 | Family Wellness: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | Family Dollar Services Inc. |
Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.
Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com.
Original recall from December 5, 2018 is here.
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