The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0201-2017·Announced 2016-12-21

Cantrell Drug Company Recalls Oxytocin Injection Bags Due to Sterility Concerns

Cantrell Drug Company is recalling 2,681 bags of Oxytocin 30 USP Units due to a lack of assurance of sterility. The affected product is 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 assurance of sterility in an intravenous drug product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Cantrell Drug Company is recalling 2,681 bags of Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only. The product is identified by Lot 9210 and NDC 52533-056-30. The recall is being conducted because the firm lacks assurance of the sterility of the product.

The affected product is distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific illnesses or injuries have been reported in the source text.

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

The recalled product

Product
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30
Manufacturer
Cantrell Drug Company
Category
Drug — Sterile Injection
Hazard
Affected units
2,681

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 (1)

  • Lot: 9210

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 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 21 products in this recall →

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