Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility
Papaverine 60 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
What was recalled
Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
- Recalling firm
- John W Hollis Inc
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1258-2014
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
See all
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
Class II · Moderate risk Terminated
BiMix Injection
Reason Lack of Assurance of Sterility
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