The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1064-2017·Announced 2017-08-16

Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling Ephedrine Sulfate syringes due to a lack of sterility assurance. The recall covers 49,666 syringes 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 sterility assurance in an injectable drug, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

Cantrell Drug Company is recalling Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL single-dose syringes. The recall is being conducted because of a lack of sterility assurance. The affected product is prescription-only and is identified by NDC 52533-118-15.

The recall includes 49,666 syringes distributed nationwide within the United States. Specific lot numbers and best-use dates are listed in the recall documentation, including lots 9904, 9914, 9939, 9952, 9969, 10004, 10043, 10088, 10115, 10269, 10431, and 10554.

Healthcare providers and patients should stop using the affected syringes and contact Cantrell Drug Company for further instructions. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
49,666

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 (18)

  • Lot #: 9904
  • 9914
  • 9939
  • BUD: 7/28/2017
  • 9952
  • 9969
  • 10004
  • BUD: 8/4/2017
  • 10043
  • 10088
  • 10115
  • BUD: 8/17/2017
  • 10269
  • BUD: 9/8/2017
  • 10431
  • BUD: 9/23/2017
  • 10554
  • BUD: 10/27/2017

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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