The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

FDA recall notice · announced February 12, 2014 · Apothecure

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

Reason for recall

Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

Notes

Distribution: Nationwide
Lot/code information: All Lots
Status: Terminated
Products in this recall event:
- The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry. (D-1066-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.