The Recall Desk
SevereFDA (Drugs)·D-1047-2013·Announced 2013-09-25

JCB Labs Recalls Epinephrine Syringes Due to Sterility Concerns

JCB Labs LLC is recalling 1,243 epinephrine syringes because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

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 and involves a risk of serious injury or death due to microbial contamination in a sterile injectable product, meeting the criteria for a Severe rating.

Plain-English summary

JCB Labs LLC is recalling 1,243 units of Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe. The product is intended for office use only. The recall affects Lot # 130806@2 with an expiry date of 09/20/2013.

The recall was initiated due to laboratory results from a contract lab indicating microbial contamination. The FDA expressed concern that test results obtained from the recalling firm's contract testing lab may not be reliable, meaning the sterility of the products cannot be assured.

The affected product was distributed nationwide and in Guam. Consumers and healthcare providers should stop using the recalled product and contact JCB Labs LLC for further instructions.

The recalled product

Product
Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
Manufacturer
JCB Labs LLC
Category
Drug — Injectable Sterile Solution
Hazard
Affected units
1,243

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)

  • Lot # 130806@2
  • Expiry 09/20/2013.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by JCB Labs LLC 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 5 products in this recall →

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