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Recall Observatory FDA recall evidence

Drug 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.

D-405-2014

October 18, 2013

Class II

Product summary

Firm
Compounding Centre At Blue Ridge
Event
Event 66568
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-405-2014

Official wording

Reason: 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.

Code information: All Lots

Distribution pattern: NC

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility