Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Ma...
FDA Drug Recall #D-1030-2018 — Class I — July 2, 2018
Recall Summary
| Recall Number | D-1030-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | July 2, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AuroMedics Pharma LLC |
| Location | East Windsor, NJ |
| Product Type | Drugs |
| Quantity | 73620 single-dose vials |
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
Reason for Recall
Presence of Particulate Matter: identified as glass and silicone material
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot: PP0317059-A; Exp February 2019: PP0317012-A, Exp: August 2019.
Other Recalls from AuroMedics Pharma LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0020-2023 | Class II | Fondaparinux Sodium Injection, USP, 7.5 mg per ... | Sep 30, 2022 |
| D-0013-2023 | Class II | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL... | Sep 26, 2022 |
| D-1551-2022 | Class III | Tranexamic Acid Injection, USP, 1000mg per 10 m... | Sep 26, 2022 |
| D-0556-2022 | Class I | Polymyxin B for Injection USP, 500,000 Units pe... | Jan 26, 2022 |
| D-0248-2021 | Class II | Acetaminophen Injection 1,000 mg per 100 mL (10... | Dec 30, 2020 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.