The Recall Desk
LowFDA (Drugs)·D-0239-2019·Announced 2018-10-31

Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate

Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution due to the presence of precipitate. The recall covers nationwide distribution.

What this means for you

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

Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a physical defect (precipitate) without reported injuries.

Plain-English summary

Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only. The recall was initiated due to the presence of precipitate in the product.

The affected product is identified by Lot # 04092018@2 with an expiration date of 12/03/2018. The recall covers distribution across the United States nationwide.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

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#: 04092018@2
  • Exp 12/03/2018

Distribution

Distributed nationwide across the United States.