Wells Pharmacy Network issues voluntary nationwide recall of sterile products due to concern for lack of sterility assurance.
ISSUE:
Wells Pharmacy Network is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to FDA concern over a lack of sterility assurance. See the press release for a listing of affected prodcuts and lot numbers.
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
BACKGROUND:
The recalled products were used for a variety of indications. No vial or portion of any lot of these medications has been found to be non sterile. All recalled products have a label that includes the name Wells Pharmacy Network, logo, drug name, and expiration date. If unsure, customers can call the pharmacy to determine if their product is on the list. To date, no adverse events have been reported.
For the full list of products being recalled, view the press release.
RECOMMENDATION:
All patients and providers that received any sterile compounded products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry, should take the following actions:
- Discontinue use of the products;
- Quarantine any unused product until further instructions are received on how to return the product
Click here to read the MedWatch safety alert, including a link to the press release.
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