FDAClass IIApril 17, 2019

Sodium Chloride Pres-free 5% Ophth Sterile* Solution recall

SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Why was Sodium Chloride Pres-free 5% Ophth Sterile* Solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 12022019@30, distributed between 09-01-2018 to 02-20-2019.

Product
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Recalling firm
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Quantity
1 prescription 20ml solution
Distribution
Dispensed in Oregon
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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