Professional Compounding Pharmacy Recalls Acetyl-L-Cysteine Eye Drops Due to Insanitary Conditions
Professional Compounding Pharmacy is recalling Acetyl-L-Cysteine 10% eye drops because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling Acetyl-L-Cysteine 10% P.F. Opth Solution, 10ml eye drops. The recall was initiated because FDA inspectors observed insanitary conditions during the compounding of sterile drugs during a recent inspection.
The affected product consists of six 10ml dropper bottles. The specific lots involved are 17012019@13, 30012019@36, 01022019@4, 14022019@1, 19022019@18, and 19022019@60. These products were distributed in Oregon between September 1, 2018, and February 20, 2019.
Consumers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Category
- Drug — Ophthalmic Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lots: 17012019@13
- 30012019@36
- 01022019@4
- 14022019@1
- 19022019@18
- 19022019@60
- distributed between 09-01-2018 to 02-20-2019.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 25 recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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