PlainRecalls
FDA Drug Moderate Class II Terminated

heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.

Reported: May 31, 2023 Initiated: April 28, 2023 #D-0731-2023

Product Description

heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.

Reason for Recall

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Details

Units Affected
11117 bags
Distribution
Nationwide in the USA.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 11117 bags.
Why was this product recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 31, 2023. Severity: Moderate. Recall number: D-0731-2023.