Ampicillin and Sulbactam for Injection recall: Particulate Matter
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6…
Why was Ampicillin and Sulbactam for Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AS0317041-A, AS0317035-A; Exp August 2019
- Product
- Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6…
- Recalling firm
- AuroMedics Pharma LLC
- Quantity
- 54,720 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- May 16, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)