FDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance
Intrathecal Compounding Specialist is recalling sterile drug preparations made from Hydromorphone Base Solution due to a lack of sterility assurance.
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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 4 to FDA Class II recalls, particularly those involving significant risks like sterility failures in sterile preparations.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for all sterile drug preparations remaining within their expiry dates that were prepared from Hydromorphone Base Solution. These products were compounded by Intrathecal Compounding Specialists in Scott, Louisiana, and dispensed between October 16, 2017, and November 17, 2017.
The recall is being conducted because of a lack of sterility assurance. The affected lots have Beyond Use Dates (BUDs) ranging from November 15, 2017, to December 16, 2017. The distribution of these products was nationwide.
Consumers and healthcare providers should stop using these specific preparations immediately. Patients who have received these drugs should contact their healthcare provider for guidance on next steps and potential health risks associated with non-sterile products.
The recalled product
- Product
- All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
- Manufacturer
- Intrathecal Compounding Specialist, LLC
- Category
- Drug — Sterile Drug Preparations
- Hazard
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 (3)
- All lots remaining within expiry (BUDs between November 15
- 2017 and December 16
- 2017).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Intrathecal Compounding Specialist, LLC 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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