The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-569-2013·Announced 2013-06-12

Carnosine 5% Eye Drops Recalled for Sterility Concerns

The Compounding Shop is recalling Carnosine 5% Opth drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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, and the hazard involves a lack of assurance of sterility in a medical product, which fits the criteria for a Severe rating (FDA Class II with potential for significant harm).

Plain-English summary

The Compounding Shop, Inc. is recalling Carnosine 5% Opth drop, 40 mL vials, compounded in St. Petersburg, Florida. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes and the lack of assurance of sterility for the product.

The affected product is distributed in Florida, California, Minnesota, and Maine. All lots of the product are included in this recall. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of the product.

Consumers who have this product should stop using it and contact The Compounding Shop, Inc. for further instructions or a refund.

The recalled product

Product
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Manufacturer
THE COMPOUNDING SHOP, INC.
Category
Drug — Compounded Ophthalmic
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 (1)

  • All Lots

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 25 recalled by THE COMPOUNDING SHOP, 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 25 products in this recall →

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