The Recall Desk
SevereFDA (Drugs)·D-0185-2017·Announced 2016-12-21

Cantrell Drug Company Recalls Phenylephrine HCl Syringes Due to Sterility Concerns

Cantrell Drug Company is recalling 30,796 syringes of Phenylephrine HCl 1 mg/10 mL due to a lack of assurance of sterility. The recall covers products 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. According to the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in a sterile drug product poses a significant risk of infection, aligning with the Severe criteria for significant injury reports or high-risk defects.

Plain-English summary

Cantrell Drug Company is recalling 30,796 syringes of Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe. The product is identified by NDC 52533-171-12. The recall is being conducted because the firm lacks assurance of the sterility of the affected drug products.

The affected lots are Lot 8502 with a best-use date of 11/21/2016, and Lot 8962 with a best-use date of 02/21/2017. These products were distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients should stop using the affected syringes and contact Cantrell Drug Company or their local FDA office for further instructions on how to return or dispose of the product.

The recalled product

Product
Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12
Manufacturer
Cantrell Drug Company
Category
Drug — Sterile Injectable
Hazard
Affected units
30,796

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 (2)

  • Lot: 8502 BUD: 11/21/2016
  • Lot: 8962 BUD: 02/21/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 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 21 products in this recall →

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Same hazard · sterility failure

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