PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 17, 2019 Initiated: February 21, 2019 #D-1088-2019

Product Description

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.

Details

Units Affected
6 prescriptions 10ml dropper bottle
Distribution
Dispensed in Oregon
Location
Corvallis, OR

Frequently Asked Questions

What product was recalled?
ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330. Recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. Units affected: 6 prescriptions 10ml dropper bottle.
Why was this product recalled?
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1088-2019.