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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

JCB Labs LLC: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Agency Publication Date: September 13, 2013
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Affected Products

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.

Lot # 130627@5, Exp 08/26/2013

Lot Numbers:
130627
Product: Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.

Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014

Lot Numbers:
130701
Product: Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

Lot # 130620@2, Exp 12/17/2013

Lot Numbers:
130620
Product: Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.

Lot # 130710@4, Exp. 01/06/2014

Lot Numbers:
130710
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.

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

Lot Numbers:
130806

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 66099
Status: Resolved
Manufacturer: JCB Labs LLC
Manufactured In: United States
Units Affected: 5 products (903 vials; 1056 vials; 397 vials; 677 vials; 1243 Syringes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.