Zosyn FDA Alerts

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

ISSUE: AuroMedics Pharma 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 products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.

BACKGROUND: Piperacillin and Tazobactam for Injection is used for treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in intra-abdominal, skin and skin structure and female pelvic infections as well as community acquired and nosocomial pneumonia.

It is packaged in a carton containing 10 single-dose vials, NDC: 55150-120-30. The affected Piperacillin and Tazobactam for Injection lots being recalled are PP0317061-A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019.

RECOMMENDATION: AuroMedics Pharma is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. 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 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. 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm

• Download form 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

[05/03/2018 - Recall Notice - FDA]

Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution

ISSUE: Apotex Corp. notified healthcare professionals it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, to the hospital/healthcare provider/user level. The impacted lots may show precipitation/ crystallization in IV bag or IV line after reconstitution. The product can also be identified by NDC number 60505-0773-00 and UPC 360505077304. The product was distributed nationwide in the United States to wholesalers, distributors, HMOs, home infusion and long term care service providers. See Press Release for a list of affected lot numbers

Hospira stated that administration of precipitated Piperacillin/Tazobactam in an IV bag or IV line may result in local reactions such as phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis (because the precipitate was visible, its particles may be large enough to cause these adverse events). In addition, the precipitation of the drug may not allow delivering a needed therapeutic dose of piperacillin and tazobactam, thus resulting in inadequate treatment of the targeted infection. This could result in adverse health consequences that could range from transient and minor impairment or complaints to permanent impairment of a body function or permanent damage to a body structure.

BACKGROUND: Piperacillin and Tazobactam for Injection is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptable, ß-lactamase producing strains of the designated microorganisms in the specified conditions such as, Appendicitis, Uncomplicated and Complicated skin and skin structures infections, Postpartum Endometritis or Pelvic Inflammatory disease, Community Acquired Pneumonia and Nosocomial Pneumonia. The product is packaged in 300 mL glass vials for reconstitution.

RECOMMENDATION: Anyone with an existing inventory of the product should stop use and distribution, quarantine the recalled lots immediately and call GENCO at 1-877-674-2078 between the hours of 7 a.m. to 5 p.m. CST, Monday through Friday, to arrange for their return.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form 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

[04/26/2013 - Press Release - Apotex]