The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0015-2017·Announced 2016-10-19

Leiter's Compounding Recalls Mitomycin Injection Due to Sterility Concerns

Leiter's Compounding is recalling Mitomycin 0.02% injections because the filters used to produce them were recalled, raising concerns about 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 significant hazard such as lack of sterility in an injectable drug corresponds to a Severe (4) rating.

Plain-English summary

Leiter's Compounding, located in San Jose, California, is recalling Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection. The product is compounded in 1 mL total volume in a 2 mL vial and is preservative-free. The recall involves 76,315 total units distributed nationwide.

The recall is being conducted due to a lack of assurance of sterility. All compounded products within their expiration dates that were produced using the recalled filters are affected. The expiration dates for the affected lots range from 11/05/2016 to 12/10/2016.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Manufacturer
Leiter's Compounding
Category
Drug — Compounded Injectable
Hazard
Affected units
76,315

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 (2)

  • All unexpired lots
  • Expirations dates of .11/05/2016 to 12/10/2016.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Leiter's Compounding 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 9 products in this recall →

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