CLASS I Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report
Heparin Sodium in 9% Sodium Chloride, Single Dose Container recalled
SCA Pharmaceuticals is recalling Heparin Sodium in 9% Sodium Chloride, Single Dose Container, distributed nationwide in the US. The recall was initiated on 29 Jul 2020 and the FDA has classified it as Class I.
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-1552-2020
- FDA event ID
- 86193
- Recalling firm
- SCA Pharmaceuticals, Windsor, CT
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Jul 2020
- FDA classified
- 27 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Blood Thinners
Timeline
| 29 Jul 2020 | Recall initiated by company | |
| 27 Aug 2020 | Classified by FDA | +29 days |
| 2 Sep 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Product as listed by the FDA
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
Where it was distributed
Nationwide within the U.S.
Questions about this recall
Is Heparin Sodium in 9% Sodium Chloride, Single Dose Container recalled?
Yes. SCA Pharmaceuticals recalled Heparin Sodium in 9% Sodium Chloride, Single Dose Container on 29 Jul 2020. The recall is Class I and its status is Terminated. Recall number D-1552-2020.
Why was it recalled?
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Which lots are affected?
Lot #: 1220019243, Exp 08/20/2020; 1220019439,1220019279, 1220019392, Exp 08/24/2020; 1220019488, Exp 08/26/2020.
Where was it sold?
Nationwide within the U.S.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 SCA Pharmaceuticals
All 166| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCcinylcholine Chloride 200 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |