Class I
Terminated
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
This recall has been terminated (originally issued February 14, 2018).
- Company
- Aurobindo Pharma Ltd.
- Recall Initiated
- January 2, 2018
- Posted
- February 14, 2018
- Recall Number
- D-0339-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 53,040 vials
- Firm Location
- Hyderabad, India
- Official Source
- View on FDA website ↗
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
distributed nationwide in the USA
Lot / Code Info
Lot Number AF0117001-A
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