The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1072-2017·Announced 2017-08-16

Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns

Cantrell Drug Company is recalling 3,039 bags of Norepinephrine Bitartrate 4 mg in 0.9% Sodium Chloride 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug is categorized as Severe (Score 4).

Plain-English summary

Cantrell Drug Company is recalling 3,039 bags of Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bags. The recall is being conducted because of a lack of sterility assurance for the affected product.

The affected product is identified by NDC 52533-134-18. The recall includes specific lots with the following lot numbers and beyond-use dates: 10069 (7/24/2017), 10090 (7/26/2017), 10121 (7/31/2017), 10142 (8/3/2017), 10183 (8/8/2017), 10360 (8/31/2017), and 10443 (9/14/2017). The product was distributed nationwide within the United States.

Healthcare providers and patients should discontinue use of the affected lots 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 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
3,039

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 (14)

  • Lot #: 10069
  • BUD: 7/24/2017
  • 10090
  • BUD: 7/26/2017
  • 10121
  • BUD: 7/31/2017
  • 10142
  • BUD: 8/3/2017
  • 10183
  • BUD: 8/8/2017
  • 10360
  • BUD: 8/31/2017
  • 10443
  • BUD: 9/14/2017

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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