FDA Recall D-0339-2018
Aurobindo Pharma Ltd. · Hyderabad, N/A
Class I — life-threatening Terminated 616 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0339-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- distributed nationwide in the USA
- Recall initiated
- 2018-01-02
- Classified by FDA Center
- 2018-02-08
- FDA published
- 2018-02-14
- Terminated
- 2019-09-10
- Recalling firm
- Aurobindo Pharma Ltd.
- Firm location
- Hyderabad, N/A, India
Drug identification
- Brand name(s)
- AMPICILLIN AND SULBACTAM
- Generic name(s)
- AMPICILLIN SODIUM AND SULBACTAM SODIUM
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-116, 55150-117, 55150-178, 55150-179- Route(s)
- INTRAMUSCULAR, INTRAVENOUS