FDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions
The FDA is recalling compounded sodium chloride eye drops from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a sterile drug compounded under insanitary conditions, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling a specific lot of compounded sodium chloride preservative-free 5% ophthalmic sterile solution. The product is a 20ml eye drop solution manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy, located in Corvallis, Oregon.
The recall was initiated because of a lack of processing controls and insanitary conditions observed during the compounding of sterile drugs during a recent FDA inspection. The affected lot number is 12022019@30, which was distributed between September 1, 2018, and February 20, 2019. The product was dispensed in Oregon.
Consumers who have this specific product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication. This recall is classified as Class II by the FDA.
The recalled product
- Product
- SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Category
- Drug — Compounded Sterile Drug
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 (2)
- Lot: 12022019@30
- 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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