What is Piperacillin and Tazobactam?
Piperacillin and Tazobactam for Injection is used to treat patients for infection caused by susceptible isolates of the designated bacteria in the patient’s skin and skin structure, intra-abdominal inflammation, and female pelvic infections. It is also used for moderate-to-severe pneumonia.
It comes in a carton containing 10 single-dose vials. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’.
Why is it being recalled?
The products have been found to contain particulate matter that was confirmed to be glass within the vial.
The administration of a glass particulate, in an intravenous drug, can result in local irritation or swelling in the best case scenario. More serious outcomes would include blockage and clotting in blood vessels, which can be life-threatening.
To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots
Which lots of Piperacillin & Tazobactam are a problem?
AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level.
The affected Piperacillin and Tazobactam for Injection lots being recalled are PP0317061-A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’. AuroMedics shipped the entire lots to wholesalers and/or hospitals nationwide Dec 6, 2017, through Apr 25, 2018.
Consumers/distributors/retailers that have the product lots which are being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
How do I return the Piperacillin & Tazobactam vials that I purchased?
Consumers with questions regarding this recall can contact AuroMedics Customer Service on weekdays from 9:00AM to 5:00PM EST at 888-238-7880 Option 1.
If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952 weekdays Monday through Friday 8:30 AM to 5:00 PM EST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm1
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The FDA website has more details about this recall.
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