Recalls / Class II
Class IID-1097-2019
Product
PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
- Affected lot / code info
- Lot: 05102018@36,27112018@49, (b) 28112018@54, distributed between 09-01-2018 to 02-20-2019.
Why it was recalled
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Recalling firm
- Firm
- Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 996 Nw Circle Blvd Ste 105, N/A, Corvallis, Oregon 97330-1485
Distribution
- Quantity
- 3 prescription 5, 10 ml injection
- Distribution pattern
- Dispensed in Oregon
Timeline
- Recall initiated
- 2019-02-21
- FDA classified
- 2019-04-09
- Posted by FDA
- 2019-04-17
- Terminated
- 2020-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1097-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.