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.
Reported: May 16, 2018 Initiated: May 1, 2018 #D-0866-2018
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 54,720 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by AuroMedics Pharma LLC. Units affected: 54,720 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 16, 2018. Severity: Critical. Recall number: D-0866-2018.
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