Reported May 16, 2018 · Terminated
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured…
AuroMedics Pharma LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile
- Manufactured forAuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20
- Lot codes and dates
Lot #: AS0317041-AAS0317035-AExp August 2019
- Amount recalled
- 54,720 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Using this product could cause serious injury, illness or death — stop using it now.
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