Agency classClass IIOur severity:Severe FDA (Drugs)·D-1584-2015·Announced 2015-09-23

Mitomycin Injection Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Mitomycin Injection 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. Per the rubric, FDA Class II recalls with potential for significant injury or property damage (such as sterility failures in injectable drugs) are classified as Severe (4).

Plain-English summary

The Compounding Pharmacy of America is recalling Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe. 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 affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates include 03102015@55 (3/9/2016), 03172015@62 (3/16/2016), and 04102015@7 (4/9/2016). The total volume of the recalled product is 315 ml.

Healthcare providers and patients should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
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 (7)

All lots distributed between November 2014 and May 2015
03102015@55
3/9/2016
03172015@62
3/16/2016
04102015@7
4/9/2016

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

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Same hazard · sterility failure