Class II · Moderate risk Terminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose…
Reason Lack of Assurance of Sterility
SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
What was recalled
SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10
- Recalling firm
- The Apothecary Shoppe LLC
- NDC code
- 99999-1775-10
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1294-2015
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 Papaverine recalls
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Class II · Moderate risk Terminated
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only…
Reason Lack of Assurance of Sterility
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