RecallRadar

FDA Drug recall D-1217-2019

NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg

On 2019-05-01 the FDA classified a Class II recall of NICARdipine 25 mg in NS 250 mL EXCEL bag, 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-1217-2019
ClassificationClass II
Statusterminated
Initiated2019-04-12
Published2019-05-01
Last updated2026-09-13 11:52 UTC
CompanyCmc Enterprise Pharmacy
DistributionNC

Product

NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason

Lack of sterility assurance.

Identifiers

code_info
Lots: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp. 5/12/2019; EB181907 Exp.…Lots: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp. 5/12/2019; EB181907 Exp. 5/19/2019; EB251910 Exp. 5/26/2019; EC111908 Exp. 6/9/2019; EC201909 Exp. 6/18/2019; EC261909 Exp. 6/24/2019; EC271919 Exp. 6/25/2019

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-1217-2019%22

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