Key Takeaway

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. by Baxter Healthcare Corp. was recalled on April 24, 2014. The hazard: Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plas...

FDA Drug Class II Terminated

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.

Recalled: April 24, 2014 ~19,152 Containers units affected D-0293-2015

Description

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.

Hazard / Reason

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.

Drugs

Company Information

Baxter Healthcare Corp.

Round Lake, IL, United States

View all 58 recalls by Baxter Healthcare Corp. →

Distribution

Nationwide

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