The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1061-2017·Announced 2017-08-16

Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling specific lots of Ephedrine Sulfate syringes due to a lack of 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, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Cantrell Drug Company is recalling 24,638 syringes of Ephedrine Sulfate in 0.9% Sodium Chloride (5 mg/mL) due to a lack of sterility assurance. The recalled product is a prescription-only single-dose syringe with NDC 52533-019-12.

The recall covers specific lots with expiration dates ranging from July 28, 2017, to September 23, 2017. These products were distributed nationwide within the United States.

Healthcare providers and patients should stop using the affected syringes and contact Cantrell Drug Company or their local FDA office for further instructions.

The recalled product

Product
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
24,638

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 (11)

  • Lot #: 9906
  • 9915 BUD: 7/28/2017
  • 9950
  • 9984
  • 10001
  • 10010
  • BUD: 8/4/2017
  • 10064
  • BUD: 8/17/2017
  • 10341
  • 10452 BUD: 9/23/2017

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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