The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1074-2017·Announced 2017-08-16

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.

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 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.

See all 18 products in this recall →

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