Class I
Terminated
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.
- Company
- Auromedics Pharma Llc
- Recall Initiated
- May 1, 2018
- Posted
- May 16, 2018
- Recall Number
- D-0866-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 54,720 vials
- Firm Location
- East Windsor, NJ, United States
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.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot #: AS0317041-A, AS0317035-A; Exp August 2019
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