FDAFDA · Food and drugs·Recall number D-0866-2018
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Published May 16, 2018 · Recall initiated: May 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMPICILLIN AND SULBACTAM
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0355150116201
- Lot
- Lot #: AS0317041-A, AS0317035-A; Exp August 2019
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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