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

FDA recall notice · announced September 4, 2013 · Fresenius Kabi

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 6103882, Exp 10/14
Quantity: 15,625 vials
Status: Terminated
Products in this recall event:
- 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 (D-920-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.