The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0495-2019·Announced 2019-02-20

Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

Tris Pharma is recalling 35,280 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

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, which corresponds to a Severe rating (score 4) under the rubric, particularly given the risk of overdose in infants due to superpotency.

Plain-English summary

Tris Pharma Inc. is recalling 35,280 bottles of Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle. The product is distributed by CVS Pharmacy, Inc. and carries NDC 50428-1252-4.

The recall is issued because the recalled lots may contain a higher concentration of ibuprofen than the amount stated on the label, a condition known as superpotency. The affected lot number is 00717006A with an expiration date of 02/19. 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 the product matches the recalled lot, consumers should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

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.
Manufacturer
Tris Pharma Inc.
Category
Drug — Pediatric OTC
Hazard
Affected units
35,280

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#: 00717006A
  • Exp 02/19

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 →

Related recalls

Same manufacturer · Tris Pharma Inc.

See all →

Same hazard · superpotency

See all →

Similar recalls