Drug product
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20
D-0339-2018
Product summary
- Event
- Event 78847
- Status
- Terminated
- Classification
- Class I
- Quantity
- 53,040 vials
- Official record key
drug-enforcement:D-0339-2018
Official wording
Reason: Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Code information: Lot Number AF0117001-A
Distribution pattern: distributed nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter