Recalls / Class I
Class ID-0866-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Brand name
- Ampicillin And Sulbactam
- Generic name
- Ampicillin Sodium And Sulbactam Sodium
- Active ingredients
- Ampicillin Sodium, Sulbactam Sodium
- Route
- Intramuscular, Intravenous
- NDCs
- 55150-116, 55150-117, 55150-178, 55150-179
- FDA application
- ANDA090349
- Affected lot / code info
- Lot #: AS0317041-A, AS0317035-A; Exp August 2019
Why it was 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.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 54,720 vials
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-05-01
- FDA classified
- 2018-06-14
- Posted by FDA
- 2018-05-16
- Terminated
- 2024-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0866-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.