Recent Compounding Pharmacy Recalls –
Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The Unexpired Sterile Drug Product Lots (include dates dispensed) are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. The inspection occurred April 20-June 12, however the Form 483 has not yet been posted. The nationwide recall includes lots of sterile drug products to the consumer/user level. Company announcement date June 18., this is the second recall due to a lack of sterility assurance (the first recall was on 4/11/18)
RXQ Compounding, LLC (“RXQ”) is voluntarily recalling all sterile human and animal products within expiry to the user level due to lack of sterility process assurance associated with the production of the Company’s sterile products. In addition, RXQ is voluntarily ceasing all sterile production at its current location as RXQ transitions into the Company’s new outsourcing facility. The Form 483 for this inspection also has not yet been posted to the FDA Website.