RecallRadar

FDA Drug recall D-1211-2019

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

On 2019-05-01 the FDA classified a Class II recall of Diltiazem 250 mg in NS 250 mL 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-1211-2019
ClassificationClass II
Statusterminated
Initiated2019-04-12
Published2019-05-01
Last updated2026-09-13 11:52 UTC
CompanyCmc Enterprise Pharmacy
DistributionNC

Product

Diltiazem 250 mg in NS 250 mL 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: EA161906 Exp. 4/16/2019; EA181906 Exp. 4/18/2019; EA231907 Exp. 4/23/2019; EA241907 Exp. 4/24/2019; EB061907 Exp.…Lots: EA161906 Exp. 4/16/2019; EA181906 Exp. 4/18/2019; EA231907 Exp. 4/23/2019; EA241907 Exp. 4/24/2019; EB061907 Exp. 5/7/2019; EB201907 Exp. 5/21/2019; EC181909 Exp. 6/16/2019

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-1211-2019%22

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