The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1062-2017·Announced 2017-08-16

Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling Ephedrine Sulfate in 0.9% Sodium Chloride single-dose syringes because of 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 the hazard involves a lack of sterility assurance in a parenteral drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Cantrell Drug Company is recalling Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL single-dose syringes (NDC 52533-019-15). The recall involves 25,529 syringes distributed nationwide within the US. The specific reason for the recall is a lack of sterility assurance.

The affected lots include 9910 and 9928 with a best-use-by date of 7/28/2017; 9962 and 9993 with a best-use-by date of 8/4/2017; and 10333, 10481, and 10538 with a best-use-by date of 9/23/2017. The product is prescription-only.

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

The recalled product

Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
25,529

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 (10)

  • Lot #: 9910
  • 9928
  • BUD: 7/28/2017
  • 9962
  • 9993
  • BUD: 8/4/2017
  • 10333
  • 10481
  • 10538
  • 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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