Status
Terminated
Drug Enforcement D-920-2013
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Classification
Class I
Report Date
September 4, 2013
Termination Date
March 10, 2016
Product Information
- 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
- Product quantity
- 15,625 vials
- Reason for recall
- Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Fresenius Kabi USA, LLC
- Address
-
3 Corporate Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-920-2013
- Event ID
- 65218
- Recall initiation date
- May 25, 2013
- Center classification date
- August 23, 2013
- Code info
- Lot #: 6103882, Exp 10/14
- More code info
- —