US Drug Recall Register
Class I · High risk Terminated Initiated Jan 2, 2018 (9 years ago)

Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was 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.

What 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

Recalling firm
Aurobindo Pharma Ltd.
NDC code
55150-116-20
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0339-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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