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.
What this means for you
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.
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