PlainRecalls
FDA Drug Moderate Class II Terminated

Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reported: May 1, 2019 Initiated: April 12, 2019 #D-1232-2019

Product Description

Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for Recall

Lack of sterility assurance.

Details

Recalling Firm
CMC Enterprise Pharmacy
Units Affected
215 bags
Distribution
NC
Location
Charlotte, NC

Frequently Asked Questions

What product was recalled?
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.. Recalled by CMC Enterprise Pharmacy. Units affected: 215 bags.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2019. Severity: Moderate. Recall number: D-1232-2019.