Recalls / Class II
Class IID-1099-2020
Product
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
- Affected lot / code info
- Lot #02282020@30, Expires after 04/28/2020
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 41538 Eastman Dr Ste A, N/A, Murrieta, California 92562-8007
Distribution
- Quantity
- N/A
- Distribution pattern
- Patient Distribution list includes addresses in the following states: CA, ME, TX
Timeline
- Recall initiated
- 2020-03-26
- FDA classified
- 2020-04-06
- Posted by FDA
- 2020-04-15
- Terminated
- 2024-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1099-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.