Recalls / Class II
Class IID-1093-2019
Product
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Affected lot / code info
- Lot: (a) 03102018@27, 07112018@18, 08112018@11, 16112018@15, 28112018@7, 14122018@37,16112018@41, 03012019@9, (b) 2012019@32, 23012019@59, (c)07022019@19, 07022019@1, (d)19122018@25, 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
- 13 prescription 5, 6, 9, 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-1093-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.