Agency classClass IIOur severity:Severe FDA (Drugs)·D-0064-2018·Announced 2017-11-08

SCA Pharmaceuticals Recalls Morphine Sulfate Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection due to a lack of assurance of sterility.

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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the snippet, the 'lack of assurance of sterility' for an injectable drug is a significant hazard that fits the Severe category for Class II drug recalls.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling specific lots of morphine sulfate 1 mg per mL in 0.9% Sodium Chloride. The affected products are available in two formats: 100 mL Single Dose CADD Cassettes (NDC 70004-0100-63) and 50 mL Single Dose Syringes (NDC 70004-0100-22). The recall is being conducted because of a lack of assurance of sterility.

The recall covers Lot 20170905@24 with a beyond-use date of 12/04/2017 and Lot 20170901@25 with a beyond-use date of 11/30/2017. These products were distributed nationwide in the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals for further instructions or to arrange for returns. Patients should consult their healthcare provider regarding alternative treatments if they are currently using these specific products.

The recalled product

Product: morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA…
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Injectable
Hazard: sterility
infection

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 (1)

Lots: a) 20170905@24 BUD: 12/04/2017 b) 20170901@25 BUD: 11/30/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by SCA Pharmaceuticals, 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 10 products in this recall →

Same manufacturer · SCA Pharmaceuticals, LLC

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Same hazard · sterility