Class II · Moderate risk
OraVerse
Defective container: cracked/broken cartridges
Papa/Phen/Prost
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Drug: Phentolamine
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0174-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phentolamine recalls
See all
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Other recalls by Fallon Wellness Pharmacy, L.L.C.
All 2016 recalls
Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk
Hydroxocobalamin 1) 1000mcg/mL
Lack of assurance of sterility
Class II · Moderate risk
Methylcobolamin 1) 6500 mcg/0.26mL
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection
Lack of assurance of sterility
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