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
Reported: September 4, 2013 Initiated: May 25, 2013 #D-920-2013
Product Description
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 15,625 vials
- Distribution
- Nationwide
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 15,625 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2013. Severity: Critical. Recall number: D-920-2013.
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