TobraDex — Class II drug recall D-0995-2022
Terminated recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-06-15, distributed nationwide. cGMP deviations: Temperature abuse
| Recall number | D-0995-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-04-13 |
| Classified | 2022-06-09 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2023-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 3 tubes |
| Reason classes | cgmp, temperature control |
| NDC | 00078-0876, 00078-0876-01 |
Product
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Reason for recall
cGMP deviations: Temperature abuse
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-0995-2022. 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.