The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1367-2020·Announced 2020-07-01

Rising Pharmaceuticals Recalls Timolol Maleate Ophthalmic Solution Due to Labeling Error

Rising Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to a carton label mix-up where 0.25% bottles were shipped in 0.5% cartons.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a minor labeling error (carton mix-up) without reported injuries or illnesses.

Plain-English summary

Rising Pharmaceuticals, Inc. is recalling a specific lot of Timolol Maleate Sterile Ophthalmic Solution USP. The recall was initiated due to a labeling error involving a mix-up of outer cartons.

The issue occurred when a case of Timolol Maleate Sterile Ophthalmic Solution USP 0.25%, 5ml, was packaged with the outer carton intended for Timolol Maleate Sterile Ophthalmic Solution USP 0.5%, 5ml. Although the bottle inside contained the 0.25% concentration, the external packaging indicated the 0.5% concentration. The affected product is Lot # 089A016, with an expiration date of 12/31/2020. The product was distributed nationwide in the U.S.A.

Consumers and healthcare providers should check their inventory for this specific lot number and concentration discrepancy. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. No adverse health consequences are expected from this labeling error, but accurate dosing is critical for ophthalmic medications.

The recalled product

Product
TIMOLOL MALEATE (TIMOLOL MALEATE)
Brand
TIMOLOL MALEATE
Manufacturer
Rising Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Solution
Hazard

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 # 089A016
  • Exp 12/31/2020

UPCs (2)

  • 0364980513050
  • 0364980514057

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Rising Pharmaceuticals, 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 2 products in this recall →

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