Photofrin — Class III drug recall D-1157-2014
Terminated recall by Pinnacle Biologics Inc, reported 2014-03-19, distributed nationwide. Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
| Recall number | D-1157-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pinnacle Biologics Inc, Bannockburn, IL, United States |
| Recall initiated | 2014-02-10 |
| Classified | 2014-03-12 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2015-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 261 vials |
| Reason classes | specification failure |
| NDC | 76128-0155, 76128-0155-75 |
| Lot numbers | 0M396 |
| Expiration dates | 2014-11-20 |
Product
Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75
Reason for recall
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
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-1157-2014. 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.