Cantrell Drug Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Sodium Bicarbonate 8.4% Injection Solution because of 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, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Cantrell Drug Company is voluntarily recalling 40,081 syringes of Sodium Bicarbonate 8.4% Injection Solution, 50 mL, 50 mEq (1mEq/mL), Single-Dose Syringe. The recall is being conducted due to a lack of sterility assurance for the affected product.
The affected product is distributed nationwide within the US. The recall covers specific lots with expiration dates ranging from July 30, 2017, to September 3, 2017. The product is prescription-only.
Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 40,081
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 (20)
- Lot#: 10349
- BUD: 7/30/2017
- 10356
- BUD: 7/31/2017
- 10377
- BUD: 8/4/2017
- 10386
- BUD: 8/5/2017
- 10394
- BUD: 8/6/2017
- 10404
- BUD: 8/8/2017
- 10423 BUD: 8/12/2017
- 10468
- BUD: 8/18/2017
- 10473
- BUD: 8/19/2017
- 10482
- BUD: 8/20/2017
- 10514
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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