FDA recall D-1088-2019

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy · Class II · drug

Product

ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Reason for recall

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Distribution

Dispensed in Oregon

Key facts

Status
Terminated
Initiation date
2019-02-21
Report date
2019-04-17
Termination date
2020-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Corvallis, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1088-2019