CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report
Glutathione 200mg/mL Injection w/Pres recalled
La Vita Compounding Pharmacy is recalling Glutathione 200mg/mL Injection w/Pres, distributed in California. The recall was initiated on 25 Jun 2018 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-0923-2018
- FDA event ID
- 80416
- Recalling firm
- La Vita Compounding Pharmacy, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2018
- FDA classified
- 13 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Jun 2018 | Recall initiated by company | |
| 13 Jul 2018 | Classified by FDA | +18 days |
| 25 Jul 2018 | 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 Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Where it was distributed
Product was distributed to patients via patient specific prescription only in CA.
Questions about this recall
Why was it recalled?
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Which lots are affected?
Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018
Where was it sold?
Product was distributed to patients via patient specific prescription only in CA.
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
2 other products · FDA event 80416This product is part of a recall event; the main page for the event is Methyl Folate CA+ 1mg/ml Injection w/Pres recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Methyl Folate CA+ 1mg/ml Injection w/Pres recalled | La Vita Compounding Pharmacy | Sterility | CA | |
| CLASS II | Methylcobalamin 1mg/mL Injection w/Pres recalled | La Vita Compounding Pharmacy | Sterility | CA |
More recalls from La Vita Compounding Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin 1mg/mL Injection w/Pres recalled | La Vita Compounding Pharmacy | Sterility | CA |
| Drug | CLASS II | Methyl Folate CA+ 1mg/ml Injection w/Pres recalled | La Vita Compounding Pharmacy | Sterility | CA |
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 |