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D-1057-2014 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1057-2014 was initiated by Baxter Healthcare Corp. on Nov 18, 2013 and is designated Class I. Reason for recall: Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. The recall status is terminated (terminated Sep 15, 2014). Affected quantity: 49,932 glass containers.

Recall Details

Product Type: Drugs
Report Date: Feb 12, 2014
Initiation Date: Nov 18, 2013
Termination Date: Sep 15, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 49,932 glass containers

Product Description

50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02

Reason for Recall

Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.

Distribution Pattern

Nationwide, Saudi Arabia and Colombia

Code Information

G105197, Exp. 02/14

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1057-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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