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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81960

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 15, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tris Pharma Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

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.

D-0493-2019
Recall number
D-0493-2019
Initiated
January 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
Tris Pharma Inc.
Quantity
46,080 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Code information

Lot#: 4718, Exp 12/19

Distribution pattern

One distributor who further distributed Nationwide in the USA.

drug · product 2 of 3

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.

D-0494-2019
Recall number
D-0494-2019
Initiated
January 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
Tris Pharma Inc.
Quantity
35,328 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Code information

Lot#: 00717005A, Exp 02/19

Distribution pattern

One distributor who further distributed Nationwide in the USA.

drug · product 3 of 3

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.

D-0495-2019
Recall number
D-0495-2019
Initiated
January 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
Tris Pharma Inc.
Quantity
35,280 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Code information

Lot#: 00717006A, Exp 02/19

Distribution pattern

One distributor who further distributed Nationwide in the USA.