The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1048-2017·Announced 2017-08-09

Hospira Recalls Quelicin Injection Due to Lack of Sterility Assurance

Hospira is recalling Quelicin (succinylcholine chloride) injection vials because they may lack sterility assurance. The recall covers 15,034,600 vials distributed in the U.S. and internationally.

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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While the specific injury reports are not detailed in the provided snippet, the Class II classification for a sterile injectable drug due to sterility assurance failure aligns with the Severe criteria for significant potential harm.

Plain-English summary

Hospira, a Pfizer company, is recalling 15,034,600 vials of Quelicin (succinylcholine chloride) Injection, USP 200 mg (20 mg/mL). The recall is being conducted due to a lack of sterility assurance for the affected product. The product is available as single vials (NDC: 0409-6629-02) and 25-vial cartons (NDC: 0409-6629-25).

The affected lots are 74393EV (exp. 05/01/2018), 75157EV (exp. 06/01/2018), 75367EV (exp. 06/01/2018), and 75158EV (exp. 06/01/2018). These products were distributed in the United States (including Puerto Rico), the Dutch Antilles, Barbados, Canada, the Philippines, Kuwait, and Singapore.

Healthcare providers and patients should stop using the affected lots of Quelicin and contact Hospira for further instructions. 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.

The recalled product

Product
QUELICIN (SUCCINYLCHOLINE CHLORIDE)
Brand
QUELICIN
Manufacturer
Hospira a Pfizer Company
Category
Drug — Injectable
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 (2)

  • Exp. 06/01/2018 b.) 25 vial carton Lot: 75158EV
  • Exp. 06/01/2018

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Hospira a Pfizer Company 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 →

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