Agency classClass IIOur severity:Severe FDA (Drugs)·D-1443-2015·Announced 2015-09-23

Compounded Ophthalmic Solution Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Ascorbic Acid, Glutathione, and DMSO Ophthalmic Solution due to FDA inspection findings of GMP violations that impact 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. According to the rubric, an FDA Class II recall involving a sterile product with GMP violations impacting sterility is assigned a score of 4 (Severe), as it represents a significant risk of harm even without reported hospitalizations.

Plain-English summary

The Compounding Pharmacy of America is recalling Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate. The product is a 13 mL sterile ophthalmic solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically lot 03032015@24 with an expiration date of 6/1/2015 and lot 03312015@79 with an expiration date of 6/29/2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations create a lack of assurance of sterility, potentially impacting the product's quality and safety. The source text does not report any specific illnesses or injuries associated with the use of this product.

Consumers and healthcare providers should stop using the recalled product and contact The Compounding Pharmacy of America for instructions on how to return or dispose of the medication. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Ophthalmic
Hazard: sterility
gmp-violation

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 (5)

All lots distributed between November 2014 and May 2015
03032015@24
6/1/2015
03312015@79
6/29/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility