The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1153-2016·Announced 2016-07-13

Cantrell Recalls Subpotent Atropine Sulfate Injection Syringes Nationwide

Cantrell Drug Company is recalling specific lots of Atropine Sulfate Injection Solution because the drug was found to be subpotent.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.

Plain-English summary

Cantrell Drug Company is voluntarily recalling specific lots of Atropine Sulfate Injection Solution, 0.4 mg/1 mL, in 1 mL and 2 mL syringes. The recall was initiated because the product was found to be subpotent, meaning it contained less of the active ingredient than labeled.

The affected products are identified by NDC 52533-010-45 and UPC 0100352533010453. The recall covers 450 syringes of the 1 mL size and 1,250 syringes of the 2 mL size. Specific lot numbers and expiration dates are listed in the recall details, including lots 149690, 151665, 149198, 151454, 151668, and 151962.

The product was distributed nationwide. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls. Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for instructions on returning the product.

The recalled product

Product
Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453
Manufacturer
Cantrell Drug Company
Category
Drug — Injection
Hazard

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 (9)

  • a) Lots: 149690
  • exp 9/14/15 and 151665
  • exp 11/5/15 and b) Lots: 149198
  • exp 9/3/15
  • 151454
  • exp 9/14/15
  • 151668
  • exp 11/5/15 and 151962
  • exp 11/11/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

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