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
Reported: February 14, 2018 Initiated: January 2, 2018 #D-0339-2018
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.
Details
- Recalling Firm
- Aurobindo Pharma Ltd.
- Units Affected
- 53,040 vials
- Distribution
- distributed nationwide in the USA
- Location
- Hyderabad, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma Ltd.. Units affected: 53,040 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Critical. Recall number: D-0339-2018.
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