CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Glutathione 100 mg/mL Injectable Vial, Use as Directed, RX recalled
Creative Compounds is recalling Glutathione 100 mg/mL Injectable Vial, Use as Directed, RX, Creative Compounds, distributed in Oregon, Washington. 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-1019-2013
- FDA event ID
- 66084
- Recalling firm
- Creative Compounds, Wilsonville, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2013
- FDA classified
- 10 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Aug 2013 | Recall initiated by company | |
| 10 Sep 2013 | Classified by FDA | +18 days |
| 18 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Where it was distributed
Oregon and Washington
Questions about this recall
Why was it recalled?
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Which lots are affected?
Lot #: 20130715@12, Exp10/13/2013
Where was it sold?
Oregon and Washington
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.
More recalls from Creative Compounds
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Betaine Anhydrous, material recalled by Creative CompoundsBetaine Anhydrous | Creative Compounds | Foreign Material | 5 states |
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 |