methylPREDNIsolone ACETATE — Class II drug recall D-0012-2018
Terminated recall by RXQ Compounding LLC, reported 2017-10-25, distributed in FL, LA, MA, OH, PA, TX. Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to steril
| Recall number | D-0012-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RXQ Compounding LLC, Athens, OH, United States |
| Recall initiated | 2017-09-25 |
| Classified | 2017-10-18 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2017-12-06 |
| Distributed | FL, LA, MA, OH, PA, TX |
| Quantity | 945 vials |
| Reason classes | sterility |
| NDC | 70731-0936-10 |
| Expiration dates | 2018-05-09 |
Product
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Reason for recall
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
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-0012-2018. 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.