Glutathione 200 mg/mL Injectable — Class II drug recall D-558-2013
Terminated recall by THE COMPOUNDING SHOP, INC., reported 2013-06-12, distributed in CA, FL, ME, MN. Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control process
| Recall number | D-558-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | THE COMPOUNDING SHOP, INC., St Petersburg, FL, United States |
| Recall initiated | 2013-05-02 |
| Classified | 2013-06-04 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2024-09-30 |
| Distributed | CA, FL, ME, MN |
| Quantity | 7 vials |
| Reason classes | sterility |
Product
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-558-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.