Agency classClass IIOur severity:Severe FDA (Drugs)·D-1582-2015·Announced 2015-09-23

Mitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Mitomycin 0.03% 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).

Plain-English summary

The Compounding Pharmacy of America is recalling Mitomycin 0.03% Ophthalmic Solution, single dose dropper, Keep Frozen. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The recall covers all lots distributed between November 2014 and May 2015. The specific lot codes and expiration dates are listed in the recall documentation. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Ophthalmic Solution
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 (20)

All lots distributed between November 2014 and May 2015
05112015@22
5/10/2016
10202014@63
10/20/2015
10272014@17
10/27/2015
11102014@20
11/10/2015
12302014@8
12/30/2015
08252014@26
8/25/2015
08262014@20
8/26/2015
09052014@13
9/5/2015
01262015@15
1/26/2016
01022015@22

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