D-0339-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- January 2, 2018
- Termination Date
- September 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,040 vials
Product Description
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
Reason for Recall
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Distribution Pattern
distributed nationwide in the USA
Code Information
Lot Number AF0117001-A