Drug recall D-0339-2018
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
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.
Lots and codes
Lot Number AF0117001-A
Recall details
- Recalling firm
- Aurobindo Pharma Ltd., Hyderabad, N/A
- Quantity
- 53,040 vials
- Distribution
- distributed nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 2, 2018
- Terminated
- September 10, 2019
Related products
- Ampicillin and Sulbactam – drug information
- NDC 55150-179 Ampicillin and Sulbactam · Ampicillin Sodium 2 g/1; Sulbactam Sodium 1 g/1 · Eugia US LLC
- NDC 55150-117 Ampicillin and Sulbactam · Ampicillin Sodium 2 g/1; Sulbactam Sodium 1 g/1 · Eugia US LLC
- NDC 55150-178 Ampicillin and Sulbactam · Ampicillin Sodium 1 g/1; Sulbactam Sodium .5 g/1 · Eugia US LLC
- NDC 55150-116 Ampicillin and Sulbactam · Ampicillin Sodium 1 g/1; Sulbactam Sodium .5 g/1 · Eugia US LLC