The Recall Desk
ModerateFDA (Drugs)·D-1160-2016·Announced 2016-07-13

Cantrell Drug Recalls Heparin Sodium Syringes Due to Stability Data Concerns

Cantrell Drug Company is recalling 4,170 syringes of Heparin Sodium in 0.45% Sodium Chloride because stability data does not support the expiration date.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or illnesses, as the hazard is theoretical based on stability data rather than confirmed harm.

Plain-English summary

Cantrell Drug Company is recalling 4,170 syringes of Heparin Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL). The product is prescription-only and was distributed nationwide. The specific lot number is 6146, with an expiration date of 9/5/15.

The recall was initiated because stability data does not support the expiration date for this product. This is an FDA Class II recall, which indicates a situation where 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.

Healthcare providers and patients should stop using the recalled product. Consumers should contact their healthcare provider for guidance on alternative treatments or replacements. The recalling firm is Cantrell Drug Company, located in Little Rock, AR.

The recalled product

Product
HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable Medication
Hazard
Affected units
4,170

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: 6146
  • exp 9/5/15

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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