The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-315-2013·Announced 2013-05-15

Hospira Recalls QUELICIN Injection Due to Sterility Concerns

Hospira Inc. is recalling QUELICIN (succinylcholine chloride) Injection due to a loose crimp on the vial that compromises 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which carries a risk of serious injury or hospitalization.

Plain-English summary

Hospira Inc. is recalling 139,200 vials of QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL. The recall is due to a lack of assurance of sterility caused by a loose crimp applied to the fliptop vial.

The affected product is identified by Lot 21-480-EV with an expiration date of 12/13. The product was distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the manufacturer for further instructions.

The recalled product

Product
QUELICIN (SUCCINYLCHOLINE CHLORIDE)
Brand
QUELICIN
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
139,200

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 21-480-EV Exp.12/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Hospira Inc. 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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