Class II · Moderate risk Ongoing
OraVerse
Reason Defective container: cracked/broken cartridges
Phentolamine 10mg/Ml Injectable 6 Ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PHENTOLAMINE 5MG/ML INJECTABLE 20 ML 50 ML (5 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1597-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Phentolamine recalls
See all
Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
BiMix STD 001
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Plus 002
Reason Lack of Assurance of Sterility
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.