Why it was recalled
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Product description
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
Lot numbers, UPCs & expiration codes
Lot #s: PP0317061-A, PP0317049-A; EXP August 2019
Where it was sold
Nationwide in the USA
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-0926-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 1, 2018
- FDA report date
- May 23, 2018
- Quantity
- 77,400 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0926-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79995
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #s: PP0317061-A, PP0317049-A; EXP August 2019
- Postal code
- 08520-1401
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0926-2018
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 77,400 vials
- Termination date
- Jun 21, 2023
- Reason for recall
- Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2018