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
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
Lack of sterility