The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0204-2017·Announced 2016-12-21

Cantrell Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride 200 mg/10 mL injection syringes because the firm cannot ensure the products are sterile.

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 involves a sterile drug product where the lack of sterility assurance poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Cantrell Drug Company is recalling 9,859 single-dose syringes of Succinylcholine Chloride 200 mg/10 mL Injection Solution (20 mg/mL). The affected products are identified by Lot 169262 with a best-use date of 1/8/2017 and Lot 169812 with a best-use date of 1/19/2017. The recall is being conducted because the firm lacks assurance of the sterility of these drug products.

The recalled products were distributed nationwide. This recall involves prescription-only medication intended for slow intravenous use. 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 immediately. Consumers should check their medication for the specific lot numbers and best-use dates listed above. If you have these products, contact your healthcare provider or the recalling firm for instructions on how to return or dispose of them safely.

The recalled product

Product
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable Medication
Hazard
Affected units
9,859

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)

  • Lot: 169262 BUD: 1/8/2017
  • Lot: 169812 BUD: 1/19/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Cantrell Drug 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 21 products in this recall →

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