Why it was recalled
Presence of Particulate Matter: identified as glass and silicone material
Product description
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
Lot numbers, UPCs & expiration codes
Lot: PP0317059-A; Exp February 2019: PP0317012-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-1030-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 2, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 73620 single-dose vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-1030-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80390
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot: PP0317059-A; Exp February 2019: PP0317012-A, Exp: August 2019.
- Postal code
- 08520-1401
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-1030-2018
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 73620 single-dose vials
- Termination date
- Oct 1, 2024
- Reason for recall
- Presence of Particulate Matter: identified as glass and silicone material
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2018