Recalls / Class II
Class IID-1535-2016
Product
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
- Affected lot / code info
- Lot#: 386606, Use by 8-9-16, 393302, Use by 10-28-16
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
- 386606 - 3 vials, 393302 - 3 vials
- 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-1535-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.