The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-784-2013·Announced 2013-07-17

Tacrolimus eye drops recalled due to sterility concerns

Olympia Pharmacy is recalling compounded tacrolimus eye drops because FDA inspection findings raised concerns about quality control and sterility assurance.

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' severity score under the rubric, particularly given the risk of sterility failure in an ophthalmic product.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of compounded tacrolimus (0.02% and 0.03%) eye drops. The recall was initiated after FDA inspection findings resulted in concerns regarding the quality control processes used to ensure the sterility of the product.

The affected products are identified by lot codes C51012 (expiration date 9/12/13) and C51201 (expiration date 9/6/13). These drops were distributed nationwide and in Puerto Rico.

Consumers who have these specific lots of tacrolimus eye drops should stop using them and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Ophthalmic
Hazard
Affected units
2

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)

  • C51012 Exp 9/12/13 and C51201 Exp 9/6/13

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 →

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