Recalls / Class I
Class ID-920-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot #: 6103882, Exp 10/14
Why it was recalled
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 15,625 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-25
- FDA classified
- 2013-08-23
- Posted by FDA
- 2013-09-04
- Terminated
- 2016-03-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-920-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.