The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1071-2017·Announced 2017-08-16

Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns

Cantrell Drug Company is recalling 1,718 bags of Norepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to 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 involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.

Plain-English summary

Cantrell Drug Company is recalling 1,718 bags of Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag. The recall is being conducted because of a lack of sterility assurance in the product.

The affected product is identified by NDC 52533-288-18. The specific lots involved are 10374 (Best Use Date: 8/4/2017), 10429 (Best Use Date: 8/13/2017), and 10532 (Best Use Date: 8/27/2017). The product was distributed nationwide within the United States.

Healthcare providers and patients should stop using the affected product and contact Cantrell Drug Company for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
1,718

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 (6)

  • Lot 3:: 10374
  • BUD: 8/4/2017
  • 10429
  • BUD: 8/13/2017
  • 10532
  • BUD: 8/27/2017

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 →

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