Cantrell Drug Recalls Adenosine Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling Adenosine in 0.9% Sodium Chloride syringes due to a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 infection or serious injury.
Plain-English summary
Cantrell Drug Company is recalling 6,210 single-dose syringes of Adenosine in 0.9% Sodium Chloride (90 mg/30 mL). The recall was initiated because of a lack of sterility assurance for the affected product.
The affected product is identified by NDC 52533-236-03. Specific lots involved in the recall are 9814 and 9831, which have a best-use date of 9/12/2017, and lot 10059, which has a best-use date of 10/18/2017. The product was distributed nationwide within the United States.
Healthcare providers and patients should stop using the affected syringes and contact Cantrell Drug Company or their local FDA office for further instructions.
The recalled product
- Product
- Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 6,210
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 (4)
- Lot #: 9814
- 9831 BUD: 9/12/2017
- 10059
- BUD: 10/18/2017
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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