CLASS II Drug recall · Reported 13 Aug 2014 · FDA Enforcement Report
Glutathione Injection USP, 200 mg/ml recalled
Medical Supply Liquidators is recalling Glutathione Injection USP, 200 mg/ml, distributed nationwide in the US. The recall was initiated on 25 Jun 2014 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-1533-2014
- FDA event ID
- 68626
- Recalling firm
- Medical Supply Liquidators, Clive, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2014
- FDA classified
- 6 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Jun 2014 | Recall initiated by company | |
| 6 Aug 2014 | Classified by FDA | +42 days |
| 13 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Where it was distributed
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Which lots are affected?
All lot numbers and exp dates
Where was it sold?
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
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
14 other products · FDA event 68626This product is part of a recall event; the main page for the event is G.A.C. 375 Injection recalled by Medical Supply Liquidators.
More recalls from Medical Supply Liquidators
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lipo 8 Injection USP 200 mg/ml recalled by Medical Supply Liquidators | Medical Supply Liquidators | Packaging Defects | Nationwide |
| Drug | CLASS II | Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml recalled | Medical Supply Liquidators | Other | Nationwide |
| Drug | CLASS II | Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml recalled | Medical Supply Liquidators | Packaging Defects | Nationwide |
| Drug | CLASS II | Vitamin B12 Methylcobalamin recalled by Medical Supply Liquidators | Medical Supply Liquidators | Other | Nationwide |
| Drug | CLASS II | Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml recalled | Medical Supply Liquidators | Other | Nationwide |
Other Glutathione recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Glutathione 200 mg/mL sterile multidose vial recalled | Optimal Balance Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Glutathione Magnesium for Injection, all strengths recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200mg/ml, a)-vial, b)-vial, Refrigerate recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200mg/mL Preservative Free, Injectable-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200mg/ML Mdv recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |