PlainRecalls
FDA Drug Moderate Class II Terminated

phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.

Reported: May 31, 2023 Initiated: April 28, 2023 #D-0735-2023

Product Description

phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.

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
1735 bags
Distribution
Nationwide in the USA.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 1735 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-0735-2023.