D-0267-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 3, 2014
- Initiation Date
- November 7, 2014
- Termination Date
- November 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 vials
Product Description
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
Reason for Recall
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.
Distribution Pattern
Kansas and Missouri
Code Information
141010I, 11/10/14; 141017F, 11/17/14;