Multi-event January 2019 FDA Recall Drug by Tris Pharma Inc.

This Multi-event Class II drug recall was voluntarily initiated by Tris Pharma Inc. on January 15, 2019 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0493-2019 TERMINATED D-0494-2019 TERMINATED D-0495-2019 TERMINATED

Recall Number: D-0493-2019

Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Initiated
01-15-2019
Reported
02-20-2019
Quantity
46,080 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81960
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tris Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
One distributor who further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 4718, Exp 12/19

Recall Number: D-0494-2019

Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Initiated
01-15-2019
Reported
02-20-2019
Quantity
35,328 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81960
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tris Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
One distributor who further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 00717005A, Exp 02/19

Recall Number: D-0495-2019

Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Initiated
01-15-2019
Reported
02-20-2019
Quantity
35,280 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81960
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tris Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
One distributor who further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 00717006A, Exp 02/19