- Company Announcement Date:
- August 18, 2020
- FDA Publish Date:
- August 18, 2020
- Product Type:
- Reason for Announcement:
Recall Reason Description
Incorrect preservative (benzyl alcohol)
- Company Name:
- SCA Pharmaceuticals
- Brand Name:
- Product Description:
Heparin Sodium Compounded products
Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not present in the product. SCA identified this labeling issue during the investigation of a low potency test result for Heparin Sodium (NDC 70004-0650-46).
Serious adverse reactions including fatal reactions and “gasping syndrome” are likely to occur in premature neonates and low-birth weight infants in the neonatal intensive care unit who receive benzyl alcohol as a preservative in infusion solutions, in any amount. Additional adverse reactions included gradual nervous system deterioration, seizures, bleeding in the skull, blood abnormalities, skin breakdown, liver and kidney failure, low blood pressure, slower than expected heart rate, and loss of sufficient brain blood flow to maintain consciousness. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Furthermore, benzyl alcohol present in mother’s serum is likely to cross into human milk and may be orally absorbed by a nursing infant. For this reason, preservative-free heparin sodium injections is recommended when heparin therapy is needed during pregnancy. Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women. SCA has not received any complaints or reports of adverse events to date related to this recall. However, out of an abundance of caution, SCA is voluntarily recalling the lots listed herein.
Heparin Sodium is used as an anticoagulant and is packaged in 500 mL or 1000 mL intravenous bags. The affected Heparin Sodium lots include the following:
|Product Description||NDC Number||Lot Number||Beyond Use Date|
|Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 500 mL Bag (5,000 units/500 mL)||70004-0650-44||1220019289||8/21/2020|
|Heparin Sodium 5 units/mL in 0.9% Sodium Chloride 500 mL Bag (2,500 units/500 mL)||70004-0655-44||1220019269||8/21/2020|
|Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 1,000 mL Bag (10,000 units/1,000 mL)||70004-0652-46||1220019457||8/24/2020|
|Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000mL Bag (5 units/mL)||70004-0650-46||1220019243||8/20/2020|
The compounded Heparin Sodium can be identified by checking the product name, concentration and lot number on the compounded bag. The compounded Heparin Sodium bags were distributed nationwide to hospitals.
SCA is notifying its customers by certified mail and is arranging for return of all recalled products. Hospitals that have compounded Heparin Sodium bags which are being recalled should stop using the product and return the product to SCA.
Consumers with questions regarding this recall can contact SCA by phone at 877-550-5059 or e-mail [email protected] between the hours of 7:00 am and 7:00 pm (Central Standard Time), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.