The Recall Desk
SevereFDA (Drugs)·D-1063-2017·Announced 2017-08-16

Cantrell Drug Company Recalls Ephedrine Sulfate Injection Syringes

Cantrell Drug Company is recalling 7,656 syringes of Ephedrine Sulfate Injection Solution due to a lack of sterility assurance. The affected products were distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no injuries are reported, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious adverse health consequences.

Plain-English summary

Cantrell Drug Company is recalling 7,656 single-dose syringes of Ephedrine Sulfate Injection Solution, 1 mL, 50 mg/1 mL (50 mg/mL). The recall is being conducted because the product lacks sterility assurance. The affected product is prescription-only and carries the NDC 52533-258-45.

The recall covers specific lots with the following lot numbers and beyond-use dates: 10099 (7/27/2017), 10127 (8/1/2017), 10208 (8/10/2017), 10254 (8/15/2017), 10278 (8/17/2017), 10303 (8/21/2017), 10371 (9/3/2017), and 10457 (9/17/2017). The affected units were distributed nationwide within the United States.

Healthcare providers and patients should check their inventory for these specific lot numbers and beyond-use dates. If the product is found, it should be quarantined and not administered. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable Solution
Hazard
Affected units
7,656

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 (16)

  • Lot #: 10099
  • BUD: 7/27/2017
  • 10127
  • BUD: 8/1/2017
  • 10208
  • BUD: 8/10/2017
  • 10254
  • BUD: 8/15/2017
  • 10278
  • BUD: 8/17/2017
  • 10303
  • BUD: 8/21/2017
  • 10371
  • BUD: 9/3/2017
  • 10457
  • BUD: 9/17/2017

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 →

Related recalls

Same manufacturer · Cantrell Drug Company

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Same hazard · lack of sterility

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