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.
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.
Lot numbers, UPCs & expiration codes
Lot #: AS0317041-A, AS0317035-A; Exp August 2019
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0866-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 1, 2018
- FDA report date
- May 16, 2018
- Quantity
- 54,720 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0866-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79996
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: AS0317041-A, AS0317035-A; Exp August 2019
- Postal code
- 08520-1401
- Report date
- May 16, 2018
- Product type
- Drugs
- Recall number
- D-0866-2018
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 54,720 vials
- Termination date
- Nov 6, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- May 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2018