CLASS II Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report
HEParin Sodium 5 USP Units/mL in 225% Sodium Chloride, in Syringe recalled
Cantrell Drug is recalling HEParin Sodium 5 USP Units/mL in 225% Sodium Chloride, in Syringe, distributed nationwide in the US. The recall was initiated on 21 Aug 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1159-2016
- FDA event ID
- 72028
- Recalling firm
- Cantrell Drug, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2015
- FDA classified
- 6 Jul 2016
- Reported
- 13 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Blood Thinners
Timeline
| 21 Aug 2015 | Recall initiated by company | |
| 6 Jul 2016 | Classified by FDA | +320 days |
| 13 Jul 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability Data Does Not Support Expiry
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212
Where it was distributed
Nationwide
Questions about this recall
Is HEParin Sodium 5 USP Units/mL in 225% Sodium Chloride, in Syringe recalled?
Yes. Cantrell Drug recalled HEParin Sodium 5 USP Units/mL in 225% Sodium Chloride, in Syringe on 21 Aug 2015. The recall is Class II and its status is Terminated. Recall number D-1159-2016.
Why was it recalled?
Stability Data Does Not Support Expiry
Which lots are affected?
Lot: 150090, exp 12/24/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cantrell Drug
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|---|---|---|---|---|---|
| Drug | CLASS II | Ephedrine Sulfate in 9% Sodium Chloride, 50 mg recalled by Cantrell Drug | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 4 mg Added to 9% Sodium Chloride recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Diltiazem HCl 125 mg in 5% Dextrose Single-Dose recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 8 mg Added to 9% Sodium Chloride recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Adenosine in 9% Sodium Chloride, 90 mg recalled by Cantrell Drug | Cantrell Drug | Sterility | Nationwide |