Skip to content
Recall Observatory FDA recall evidence

Drug product

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57

D-0262-2015

November 07, 2014

Class II

Product summary

Firm
Perry Drug Inc.
Event
Event 69674
Status
Terminated
Classification
Class II
Quantity
5 vials
Official record key
drug-enforcement:D-0262-2015

Official wording

Reason: Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information: 141007DD, 11/7/14; 141015GG, 11/15/14; 141031II, 12/1/2014; 141031AA, 11/31/14; 141031JJ, 12/1/14;

Distribution pattern: Kansas and Missouri

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility