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.
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 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
- 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
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.
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