Recalls You Should Know About—Week of July 30, 2018

We’ve compiled a list of product recalls issued by the US Food and Drug Administration (FDA) from this past week.

Ranier’s Rx Laboratory Recalls Sterile Compounded Products Due to Concern of Lack of Sterility

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level.

These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy conducted by FDA.

To date, the FDA is not aware of any adverse events associated with the use of compounded drug products from the pharmacy nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority.

The recall encompasses compounded sterile drug products, within expiry, that were dispensed between January 17, 2018, and July 10, 2018.

For additional details related to this recall, read the news release.

Lipari Foods Issues Recall of Premo Fresh Grab Turkey & Swiss Sandwiches Due to Potential Listeria Contamination

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes.

The products were produced on July 17, 2018 and distributed to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

For more details about this recall, check out the official announcement.

AuroMedics Pharma LLC Recalls Piperacillin and Tazobactam for Injection 3.375 grams per viral Due to Presence of Glass and Silicone

AuroMedics Pharma LLC is voluntarily recalling 2 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.

One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was found to contain silicone material. This problem was discovered as a result of 2 product complaints in which the contents of 1 vial from batch PP0317012-A was found to contain a glass particle and the contents of one vial from batch PP0317059A was found to contain a silicone particle.

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 PP0317059-A; Exp. February 2019: PP0317012-A, Exp. August 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 lot PP0317012-A to wholesalers and/or hospitals nationwide June 30, 2017. Lot PP0317059-A was shipped November 27, 2017 through January 29, 2018.

For more information on the recalled products, read the official statement.