Recalls / Class II
Class IID-0262-2015
Product
Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
- Affected lot / code info
- 141007DD, 11/7/14; 141015GG, 11/15/14; 141031II, 12/1/2014; 141031AA, 11/31/14; 141031JJ, 12/1/14;
Why it was recalled
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.
Recalling firm
- Firm
- Perry Drug Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12200 W 106th St Ste 140, N/A, Overland Park, Kansas 66215-2305
Distribution
- Quantity
- 5 vials
- Distribution pattern
- Kansas and Missouri
Timeline
- Recall initiated
- 2014-11-07
- FDA classified
- 2014-11-24
- Posted by FDA
- 2014-12-03
- Terminated
- 2015-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0262-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.