The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0059-2018·Announced 2017-11-08

SCA Pharmaceuticals Recalls Succinylcholine Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 1,248 syringes of Succinylcholine 20 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.

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 corresponds to a Severe rating under the rubric for significant injury risks such as sterility failures in injectable medications.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling 1,248 syringes of SUCcinylcholine 20 mg per mL (Total Volume 10 mL). The product is a prescription-only medication identified by NDC 70004-0910-29. The specific lot affected is 20170726@35, with a beyond-use date of 10/24/2017.

The recall was initiated because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the medication is free from microorganisms, which poses a risk of infection if administered.

The affected product was distributed nationwide in the United States. Healthcare providers and patients should stop using the recalled lot and contact SCA Pharmaceuticals for further instructions or replacement.

The recalled product

Product
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
Affected units
1,248

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)

  • Lot: 20170726@35 BUD: 10/24/2017

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 →

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