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Recall Observatory FDA recall evidence

Drug product

Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.

D-1069-2013

September 06, 2013

Class II

Product summary

Firm
Triangle Compounding
Event
Event 66297
Status
Terminated
Classification
Class II
Quantity
8 vials
Official record key
drug-enforcement:D-1069-2013

Official wording

Reason: Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Code information: Lot 74651-LG4973, Exp 12/4/13

Distribution pattern: NC

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility