Pinnacle Biologics Recalls Photofrin Due to Incorrect Expiration Date
Pinnacle Biologics is recalling 261 vials of Photofrin (porfimer sodium) because the printed expiration date is incorrect.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or manufacturing regulations that is not likely to cause adverse health consequences. The issue is a documentation error regarding the expiration date.
Plain-English summary
Pinnacle Biologics, Inc. is recalling 261 vials of Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial. The product is a prescription-only medication manufactured for Pinnacle Biologics, Inc. in Bannockburn, IL. The affected lot number is 0M396.
The recall was initiated because stability data does not support the printed expiration date. The printed expiration date on the vials is November 2014, but it should be November 2013. This discrepancy means the product may have been used past its intended stability period.
The affected product was distributed nationwide in the United States and in Taiwan. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the distributor or manufacturer for credit.
The recalled product
- Product
- PHOTOFRIN (PORFIMER SODIUM)
- Brand
- PHOTOFRIN
- Manufacturer
- Pinnacle Biologics Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 261
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 0M396
- Expiry: Nov 2014
UPCs (1)
- 0376128155756
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighAdrenalin Epinephrine Injection Recalled Due to Incorrect Expiration Date Label
FDA (Drugs) · 2024-02-28
- ModeratePantoprazole Sodium Injection 40 mg Recalled Due to Manufacturing Procedure Deviation
FDA (Drugs) · 2023-05-03
- ModerateAstellas Recalls Mycamine Injection Vials Due to Labeling Error
FDA (Drugs) · 2018-02-14
- ModerateMylan Recalls Aloprim Injection Vials Due to Discoloration
FDA (Drugs) · 2020-05-27
- LowPfizer Recalls Premarin Tablets Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2016-10-05
- SeverePharmakon Recalls Epinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20