RecallWatchUSA

Home / Recalls / Drugs

Compounding Centre At Blue Ridge recalls PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge

Recalled January 15, 2014 · FDA recall D-402-2014 · Compounding Centre At Blue Ridge

Hazard
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. · FDA Class II
Units
11 units
Sold at
NC

Description

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Product
PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Manufacturer(s)
Compounding Centre At Blue Ridge

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Compounding Centre At Blue Ridge recalls PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge | RecallWatchUSA