The Recall Desk
SevereFDA (Drugs)·D-0018-2017·Announced 2016-10-19

Leiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns

Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), especially given the strict rule that FDA Class I/II classifications generally warrant higher severity scores than theoretical risks.

Plain-English summary

Leiter's Compounding, located in San Jose, California, is recalling Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free). The recall affects 76,315 total units distributed nationwide. The specific NDC number for the product is 70360-005-35.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that all compounded products within their expiry dates were produced using recalled filters. The affected lots have expiration dates ranging from 10/05/2016 to 01/10/2017.

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

The recalled product

Product
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (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 — 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 10/05/2016 to 01/10/2017

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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Same hazard · sterility

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