Recalls / Class II
Class IID-0267-2015
Product
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
- Affected lot / code info
- 141010I, 11/10/14; 141017F, 11/17/14;
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
- 2 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-0267-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.