FDAClass IIApril 17, 2019

Acetyl-l-cysteine 10% P.f. Ophth Solution recall

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

Why was Acetyl-l-cysteine 10% P.f. Ophth 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?

Lots: 17012019@13, 30012019@36, 01022019@4, 14022019@1, 19022019@18, 19022019@60, distributed between 09-01-2018 to 02-20-2019.

Product
ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, 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
6 prescriptions 10ml dropper bottle
Distribution
Dispensed in Oregon
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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