drugs Class II Updated 2014-01-15

Compounding Centre At Blue Ridge recalls Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units R

Recalled Product

Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

Hazard / Issue

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.

Issued by

FDA

Affected States: NC
Lot/Code Info: All Lots
View official government recall

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