CLASS II Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report
Acetylcysteine 20% Solution recalled by JCB Labs
JCB Labs is recalling Acetylcysteine 20% Solution, Preservative Free Sterile Single Dose Vial, Not for, distributed nationwide in the US. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1043-2013
- FDA event ID
- 66099
- Recalling firm
- JCB Labs, Wichita, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2013
- FDA classified
- 13 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Aug 2013 | Recall initiated by company | |
| 13 Sep 2013 | Classified by FDA | +21 days |
| 25 Sep 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
Where it was distributed
Nationwide and Guam
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # 130627@5, Exp 08/26/2013
Where was it sold?
Nationwide and Guam
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 66099This product is part of a recall event; the main page for the event is Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection recalled | JCB Labs | Sterility | Nationwide | |
| CLASS II | Sodium Thiosulfate 25%, 250 mg/mL, PF Sterile Solution recalled | JCB Labs | Sterility | Nationwide | |
| CLASS II | Sodium Citrate 4% containing Gentamicin 320 mcg/mL recalled by JCB Labs | JCB Labs | Sterility | Nationwide | |
| CLASS II | Sodium Citrate 4% Solution for Injection Multi Dose Vial recalled | JCB Labs | Sterility | Nationwide |
More recalls from JCB Labs
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Citrate 4% Solution for Injection Multi Dose Vial recalled | JCB Labs | Sterility | Nationwide |
| Drug | CLASS II | Sodium Citrate 4% containing Gentamicin 320 mcg/mL recalled by JCB Labs | JCB Labs | Sterility | Nationwide |
| Drug | CLASS II | Sodium Thiosulfate 25%, 250 mg/mL, PF Sterile Solution recalled | JCB Labs | Sterility | Nationwide |
| Drug | CLASS II | Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection recalled | JCB Labs | Sterility | Nationwide |
Other Acetylcysteine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine 10% Ophthalmic Solution recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Ophthalmic Solution, 100mg/ml recalled | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |