Cantrell Drug Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride Injection Solution due to a lack of 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Cantrell Drug Company is recalling 18,015 single-dose syringes of Succinylcholine Chloride Injection Solution, 5 mL, 100 mg/5 mL (20 mg/mL). The recall is being conducted because of a lack of sterility assurance for the affected product.
The recalled product is distributed nationwide within the US. The specific lots affected are 10076, 10106, 10145, 10220, 10298, 10400, 10446, and 10548. These lots have best-use dates ranging from July 24, 2017, to September 27, 2017.
Healthcare providers and patients should discontinue use of the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 18,015
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 (16)
- Lot #: 10076
- BUD: 7/24/2017
- 10106
- BUD: 7/27/2017
- 10145
- BUD: 8/2/2017
- 10220
- BUD: 8/13/2017
- 10298
- BUD: 8/20/2017
- 10400
- BUD: 9/6/2017
- 10446
- BUD: 9/14/2017
- 10548
- BUD: 9/27/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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.
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