The Recall Desk
SevereFDA (Drugs)·D-1079-2017·Announced 2017-08-16

Cantrell Drug Company Recalls Rocuronium Bromide Injection Due to Sterility Concerns

Cantrell Drug Company is recalling specific lots of Rocuronium Bromide Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide in the US.

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, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance in an injectable drug) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High.

Plain-English summary

Cantrell Drug Company is recalling 28,779 single-dose syringes of Rocuronium Bromide Injection Solution, 5 mL, 50 mg/5 mL (10 mg/mL). The recall is being conducted because of a lack of sterility assurance for the product.

The affected product is identified by NDC 52533-064-15. Specific lot numbers and best use dates involved in the recall include: 9598 (BUD 8/2/2017), 9609 (BUD 8/5/2017), 9621 (BUD 8/7/2017), 9681 (BUD 8/19/2017), 9765 (BUD 9/5/2017), 10102 (BUD 10/24/2017), 10347 (BUD 11/26/2017), 10357 (BUD 11/26/2017), 10387 (BUD 12/3/2017), and 10478, 10505, and 10585 (BUD 12/16/2017).

The product was distributed nationwide within the United States. Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the manufacturer for further instructions.

The recalled product

Product
Rocuronium Bromide Injection Solution 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 52533-064-15
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
28,779

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 (20)

  • Lot #: 9598
  • BUD: 8/2/2017
  • 9609
  • BUD: 8/5/2017
  • 9621
  • BUD: 8/7/2017
  • 9681
  • BUD: 8/19/2017
  • 9765
  • BUD: 9/5/2017
  • 10102
  • BUD: 10/24/2017
  • 10347
  • BUD: 11/26/2017
  • 10357
  • 10387
  • BUD: 12/3/2017
  • 10478
  • 10505
  • 10585

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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