Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV — Class II drug recall D-0251-2018
Terminated recall by Premier Pharmacy Labs Inc, reported 2018-02-07, distributed nationwide. Labeling: Label Error on Declared Strength
| Recall number | D-0251-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Premier Pharmacy Labs Inc, Weeki Wachee, FL, United States |
| Recall initiated | 2018-01-11 |
| Classified | 2018-02-02 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 193 vials |
| Reason classes | labeling, potency |
| NDC | 69623-0160-35 |
| Lot numbers | MIT100217SVDS |
| Expiration dates | 2018-03-01 |
Product
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Reason for recall
Labeling: Label Error on Declared Strength
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-0251-2018. 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.