The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1078-2017·Announced 2017-08-16

Cantrell Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns

Cantrell Drug Company is recalling Neostigmine Methylsulfate Injection Solution due to a lack of sterility assurance. The affected syringes were 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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug corresponds to a severity score of 4 (Severe).

Plain-English summary

Cantrell Drug Company is recalling Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringes. The recall was initiated because of a lack of sterility assurance in the product.

The affected product is identified by NDC 52533-046-15. The recall covers 120,856 syringes with specific lot numbers and best-use dates ranging from July 25, 2017, to October 6, 2017. These products were distributed nationwide within the United States.

Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard
Affected units
120,856

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 #: 10081
  • BUD: 7/25/2017
  • 10096
  • BUD: 7/27/2017
  • 10112
  • BUD: 7/30/2017
  • 10117
  • BUD: 7/31/2017
  • 10152
  • BUD: 8/3/2017
  • 10159
  • BUD: 8/6/2017
  • 10170
  • BUD: 8/7/2017
  • 10174
  • BUD: 8/8/2017
  • 10193
  • BUD: 8/9/2017
  • 10202
  • BUD: 8/10/2017

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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