The Recall Desk
SevereFDA (Drugs)·D-1070-2017·Announced 2017-08-16

Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns

Cantrell Drug Company is recalling 8,928 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL 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 8,928 bags of Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag. The recall is being conducted because of a lack of sterility assurance. The affected product is prescription-only and was distributed nationwide within the US.

The recall covers specific lots with expiration dates ranging from July 27, 2017, to September 27, 2017. The affected lot numbers are 10095, 10119, 10135, 10162, 10168, 10186, 10247, 10301, 10325, 10390, 10465, 10487, and 10542.

Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
8,928

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 #: 10095
  • BUD: 7/27/2017
  • 10119
  • BUD: 7/31/2017
  • 10135
  • BUD: 8/2/2017
  • 10162
  • BUD: 8/6/2017
  • 10168
  • BUD: 8/7/2017
  • 10186
  • BUD: 8/9/2017
  • 10247
  • BUD: 8/15/2017
  • 10301
  • BUD: 8/21/2017
  • 10325
  • BUD: 8/24/2017
  • 10390
  • BUD: 9/5/2017

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.

See all 18 products in this recall →

Related recalls

Same manufacturer · Cantrell Drug Company

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Same hazard · lack of sterility

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