Recalls / Class II
Class IID-1547-2016
Product
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
- 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
- 1vial
- 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-1547-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.