Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility
At-1
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
What was recalled
AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- NDC code
- 73198-0039-10
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0802-2022
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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