Class II · Moderate risk Ongoing
OraVerse
Reason Defective container: cracked/broken cartridges
Forskolin/Papavarine/Phentolamine 200mcg/40mg/3mg/Ml Injectable 5 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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 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-1523-2012
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
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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
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