Drug 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
D-920-2013
Product summary
- Event
- Event 65218
- Status
- Terminated
- Classification
- Class I
- Quantity
- 15,625 vials
- Official record key
drug-enforcement:D-920-2013
Official wording
Reason: Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Code information: Lot #: 6103882, Exp 10/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter