Agency classClass IIOur severity:Severe FDA (Drugs)·D-0322-2018·Announced 2018-02-14

FDA Recalls Sterile Morphine Sulfate Preparations Due to Sterility Concerns

Intrathecal Compounding Specialist, LLC is recalling sterile morphine sulfate preparations compounded between October 16 and November 17, 2017, 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in sterile drug preparations, which poses a significant risk of serious injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for all sterile drug preparations prepared from Morphine Sulfate PF 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 includes all lots remaining within their expiration dates, specifically those with a beyond-use date (BUD) between November 15, 2017, and December 16, 2017.

The recall was initiated due to a lack of sterility assurance. The source text does not specify the exact nature of the sterility failure or report any specific illnesses or injuries associated with the use of these products. The distribution pattern for the affected products is listed as nationwide.

Healthcare providers and patients who have received these specific morphine sulfate preparations should contact their healthcare provider for guidance. The FDA advises that these products should not be used until further notice. Consumers should verify the compounding facility and dispensing dates to determine if their medication is affected.

The recalled product

Product: All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF 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 Compounded Medication
Hazard: lack-of-sterility

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 (BUD 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.

See all 4 products in this recall →

Same manufacturer · Intrathecal Compounding Specialist, LLC

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Same hazard · lack of sterility