The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0493-2019·Announced 2019-02-20

Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

Tris Pharma is recalling specific lots of Infants' Ibuprofen because the medication may contain a higher concentration of ibuprofen than labeled.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a superpotent drug with higher concentration than labeled, which poses a significant risk of serious injury or adverse health consequences.

Plain-English summary

Tris Pharma Inc. is recalling 46,080 bottles of Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP. The product is a 0.5 FL OZ (15 mL) bottle, dye-free, non-staining berry flavor, distributed by CVS Pharmacy, Inc. The specific lot number is 4718, with an expiration date of 12/19.

The recall was initiated because the recalled lots may have a higher concentration of ibuprofen than the amount stated on the label. This is classified as a superpotent drug issue. The product was distributed nationwide in the USA through one distributor.

Consumers should check their inventory for the specific lot number and expiration date listed above. If they have this product, they should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

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.
Manufacturer
Tris Pharma Inc.
Category
Drug — Ophthalmic / Injectable / Oral
Hazard
Affected units
46,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: 4718
  • Exp 12/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Tris Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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