Laureth-9 Injectable Solution Recalled for Lack of Sterility Assurance
A compounded Laureth-9 injectable solution has been recalled after the FDA found the manufacturing process could not guarantee sterility. The recalled product (lot 66513) was distributed in AL, LA, MS, and TN.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for lack of sterility assurance in a compounded injectable. No illnesses have been reported, but loss of sterility in products intended for injection poses significant infection risk due to direct entry into the body.
Plain-English summary
Pharmacy Plus, Inc., operating as Vital Care Compounder, is recalling Laureth-9 INJ 2% Solution in 30 mL vials. The recalled product is lot 66513 with a beyond-use date of 11/10/2022. It was manufactured at 115 S. 40th Ave., Hattiesburg, MS 39402.
The FDA conducted an inspection and determined that the recalled products were manufactured in a manner that cannot guarantee the sterility of these products. Sterility is essential for injectable medications, as injectables bypass the body's natural protective barriers.
The recalled vials were distributed to pharmacies in Alabama, Louisiana, Mississippi, and Tennessee.
Patients who have received this product should consult their prescribing healthcare provider. Healthcare providers and pharmacies should discontinue dispensing this lot and segregate any remaining inventory.
The recalled product
- Product
- LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- contamination-risk
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: 66513
- BUD: 11/10/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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