Class II
Terminated
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
- Company
- Tris Pharma Inc.
- Recall Initiated
- January 15, 2019
- Posted
- February 20, 2019
- Recall Number
- D-0493-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46,080 bottles
- Firm Location
- Monmouth Junction, NJ, United States
Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Distribution
One distributor who further distributed Nationwide in the USA.
Lot / Code Info
Lot#: 4718, Exp 12/19
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