FDA recall D-920-2013

Product

Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50

Reason for recall

Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-05-25

Report date

2013-09-04

Termination date

2016-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-920-2013