CLASS II Drug recall · Reported 9 Jan 2019 · FDA Enforcement Report
Glutathione liquid, 200mg/ml, Rx recalled by Hiers Enterprises
Hiers Enterprises is recalling Glutathione liquid, 200mg/ml, Rx, distributed in Oregon. The recall was initiated on 2 Jan 2019 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-0407-2019
- FDA event ID
- 81883
- Recalling firm
- Hiers Enterprises, Roseburg, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 27 Jan 2019
- Reported
- 9 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 9 Jan 2019 | Published in enforcement report | +7 days |
| 27 Jan 2019 | Classified by FDA | +18 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 sterility assurance.
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
Glutathione liquid, 200mg/ml, Rx
Where it was distributed
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Questions about this recall
Is Glutathione liquid, 200mg/ml, Rx recalled?
Yes. Hiers Enterprises recalled Glutathione liquid, 200mg/ml, Rx on 2 Jan 2019. The recall is Class II and its status is Terminated. Recall number D-0407-2019.
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
10092018@5
Where was it sold?
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.