Class I · High risk
MitoXANTRONE Injection
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Photofrin (porfimer sodium)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
76128-0155-75
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Photofrin Porfimer Sodium NDC 76128-0155 |
75 mg/31.8mL | Injection, Powder, for Solution Intravenous |
Pinnacle Biologics, Inc. | Rx |
- Recalling firm
- Pinnacle Biologics Inc
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1157-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other stability / shelf life recalls from 2014
All stability / shelf life recalls
Class II · Moderate risk
Ticarcillin Sodium/Potassium Clavulanate
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
Procaine Penicillin G active pharmaceutical ingredient packaged…
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
Piperacillin Sodium active pharmaceutical ingredient packaged in…
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.