Cantrell Drug Recalls Phenylephrine Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Phenylephrine HCL syringes because they may lack sterility assurance. The affected products were distributed nationwide.
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 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 46,078 single-dose syringes of Phenylephrine HCL in 0.9% Sodium Chloride (1 mg/10 mL). The recall is being conducted because the product lacks sterility assurance. The affected product is prescription-only and is identified by NDC 52533-171-12.
The recall covers specific lots with expiration dates ranging from July 26, 2017, to October 30, 2017. These products were distributed nationwide within the United States. The source text does not report any specific illnesses or injuries associated with the use of these syringes.
Healthcare providers and patients should discontinue use of the affected lots. Cantrell Drug Company is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 46,078
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 #: 9556
- BUD: 7/26/2017
- 9566
- BUD: 7/30/2017
- 9584
- BUD
- 8/1/2017
- 9613
- BUD: 8/6/2017
- 9656
- BUD: 8/14/2017
- 9798
- BUD: 9/11/2017
- 9812
- BUD: 8/31/2017
- 9819
- BUD: 9/16/2017
- 9836
- BUD: 9/17/2017
- 9944
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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