D-0495-2019 Class II Terminated
FDA drug recall D-0495-2019 was initiated by Tris Pharma Inc. on Jan 15, 2019 and is designated Class II. Reason for recall: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. The recall status is terminated (terminated Mar 29, 2023). Affected quantity: 35,280 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 20, 2019
- Initiation Date
- Jan 15, 2019
- Termination Date
- Mar 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,280 bottles
Product Description
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Distribution Pattern
One distributor who further distributed Nationwide in the USA.
Code Information
Lot#: 00717006A, Exp 02/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0495-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026