Why it was recalled
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Product description
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
Lot numbers, UPCs & expiration codes
Lot Number: 0M396; Expiry: Nov 2014
Where it was sold
US: Nationwide and Taiwan
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1157-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 10, 2014
- FDA report date
- Mar 19, 2014
- Quantity
- 261 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pinnacle Biologics Inc
Original FDA data
Every field from FDA enforcement report D-1157-2014, exactly as published.
Show all FDA fields
- City
- Bannockburn
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67688
- Address
- 2801 Lakeside Dr Ste 209
- Code information
- Lot Number: 0M396; Expiry: Nov 2014
- Postal code
- 60015-1271
- Report date
- Mar 19, 2014
- Product type
- Drugs
- Recall number
- D-1157-2014
- Classification
- Class III
- Recalling firm
- Pinnacle Biologics Inc
- Product quantity
- 261 vials
- Termination date
- May 22, 2015
- Reason for recall
- Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US: Nationwide and Taiwan
- Recall initiation date
- Feb 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2014