Agency classClass IIOur severity:Severe FDA (Drugs)·D-1581-2015·Announced 2015-09-23

Mitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Mitomycin 0.02% Ophthalmic Solution due to FDA inspection findings of GMP violations that may 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 source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly given the risk of sterility failure in an ophthalmic product.

Plain-English summary

The Compounding Pharmacy of America is recalling Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen. The product was distributed nationwide between November 2014 and May 2015. The recall involves 78 ml total volume across multiple lots with expiration dates ranging from June 2015 to March 2016.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product: Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Ophthalmic Solution
Hazard: sterility-failure
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 (17)

All lots distributed between November 2014 and May 2015
06132014@45
6/13/2015
02032015@82
2/3/2016
03242015@26
3/23/2016
08142014@46
8/14/2015
07172014@54
7/17/2015
12032014@77
12/3/2015
03102015@23
3/9/2016
03042015@44
3/3/2016

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

See all →

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Same hazard · sterility failure