The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-707-2013·Announced 2013-07-17

FDA Recalls Compounded Dexamethasone Eye Ointment Over Sterility Concerns

Olympia Pharmacy is recalling one unit of compounded BNP/dexamethasone eye ointment because FDA inspection findings raised concerns about sterility assurance and quality control. The listed distribution is nationwide and Puerto Rico.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified by FDA as Class II, but the source does not report hospitalizations, so the rubric's Severe criterion is not met. The source contains no report of injury, and the sterility-assurance concern is a risk-of-harm issue, supporting a High rating under the rubric's risk-of-harm criterion.

Plain-English summary

The FDA is recalling one unit of BNP/dexamethasone eye ointment compounded by Lowlite Investments, Inc. d/b/a Olympia Pharmacy in Orlando, Florida. The listed code is B5119, with expiration date 10/31/13.

FDA inspection findings raised concerns about the product's quality-control processes and created a lack of assurance that the ointment was sterile.

The recall lists distribution as nationwide and Puerto Rico. The provided source text does not state what consumers should do.

The recalled product

Product
BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Eye Ointment
Hazard
Affected units
1

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 (1)

  • B5119 exp 10/31/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy 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 105 products in this recall →

Related recalls

Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls