The Recall Desk
SevereFDA (Drugs)·D-1073-2017·Announced 2017-08-16

Cantrell Drug Recalls Diltiazem HCl Bags Due to Sterility Concerns

Cantrell Drug Company is recalling Diltiazem HCl 125 mg in 5% Dextrose single-dose bags because of a lack of sterility assurance. The recall covers 2,761 bags 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 and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Cantrell Drug Company is recalling Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose Bags. The recall was initiated due to a lack of sterility assurance in the product. The affected product is prescription-only and is identified by NDC 52533-103-13.

A total of 2,761 bags are included in this recall. The affected lots are 10084, 10137, 10252, 10271, 10350, and 10491, with best-use dates ranging from July 25, 2017, to September 21, 2017. The product was distributed nationwide within the United States.

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

The recalled product

Product
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Affected units
2,761

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 (12)

  • Lot #: 10084
  • BUD: 7/25/2017
  • 10137
  • BUD: 8/2/2017
  • 10252
  • BUD: 8/15/2017
  • 10271
  • BUD: 8/17/2017
  • 10350
  • BUD: 8/30/2017
  • 10491
  • BUD: 9/21/2017

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 →