JCB Labs Recalls Acetylcysteine Solution Due to Sterility Concerns
JCB Labs LLC is recalling 903 vials of Acetylcysteine 20% Solution 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 microbial contamination where sterility cannot be assured, which poses a significant risk of serious health consequences if the product is used in a clinical setting.
Plain-English summary
JCB Labs LLC is voluntarily recalling 903 vials of Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial. The product is labeled "Not for Injection" and "Sterile Solution For Office Use Only." The recall affects Lot # 130627@5 with an expiration date of 08/26/2013.
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 product was distributed nationwide and to Guam.
Consumers and healthcare providers should stop using the affected product and return it to the source of purchase or contact JCB Labs LLC for further instructions.
The recalled product
- Product
- Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
- Manufacturer
- JCB Labs LLC
- Category
- Drug — Sterile Solution
- Affected units
- 903
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 # 130627@5
- Exp 08/26/2013
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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