Recalls / Class II
Class IID-1545-2016
Product
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
- Affected lot / code info
- Lot# 397877, USE BY 1-6-17
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 115 S 40th Ave, N/A, Hattiesburg, Mississippi 39402-6600
Distribution
- Quantity
- 1 vial
- Distribution pattern
- MS
Timeline
- Recall initiated
- 2016-07-26
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2016-11-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1545-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.