The Recall Desk
SevereFDA (Drugs)·D-0337-2019·Announced 2018-12-26

Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

Tris Pharma is recalling specific lots of Infants' Ibuprofen because they may contain a higher concentration of the active ingredient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a superpotent drug (higher concentration of ibuprofen) which poses a significant risk of serious injury or adverse health consequences, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Tris Pharma Inc. is recalling 20,736 bottles of Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle. The product is distributed by CVS Pharmacy, Inc. The affected lot number is 00717024A with an expiration date of 08/19.

The recall was initiated because the recalled lots may have a higher concentration of ibuprofen than intended. This is classified as a superpotent drug issue. The product was distributed to one distributor in Pennsylvania, who further distributed the product nationwide in the USA.

Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled description, it should not be used. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or disposal instructions.

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.
Manufacturer
Tris Pharma Inc.
Category
Drug — Ophthalmic / Injectable / Oral
Hazard
Affected units
20,736

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 #: 00717024A
  • Exp 08/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Related recalls

Same manufacturer · Tris Pharma Inc.

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Same hazard · superpotent drug

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