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.

FDA recall notice · announced September 25, 2013 · Jcb Labs

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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.

Notes

Distribution: Nationwide and Guam
Lot/code information: Lot # 130806@2, Expiry 09/20/2013.
Quantity: 1243 Syringes
Status: Terminated
Products in this recall event:
- 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. (D-1044-2013)
- Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS. (D-1043-2013)
- 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. (D-1045-2013)
- Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS. (D-1046-2013)
- 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. (D-1047-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.