RecallRadar

FDA Drug recall D-1234-2019

Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg

On 2019-05-01 the FDA classified a Class II recall of Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg by Cmc Enterprise Pharmacy, citing lack of sterility assurance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1234-2019
ClassificationClass II
Statusterminated
Initiated2019-04-12
Published2019-05-01
Last updated2026-09-13 11:52 UTC
CompanyCmc Enterprise Pharmacy
DistributionNC

Product

Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason

Lack of sterility assurance.

Identifiers

code_infoLots: ED031915 Exp. 4/17/2019; ED041919 Exp. 4/18/2019; ED091914 Exp. 4/23/2019; ED111912 Exp. 4/25/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1234-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.