Drug product
HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
D-0272-2015
Product summary
- Firm
- Perry Drug Inc.
- Event
- Event 69674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0272-2015
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: 141021DD, 11/21/14;
Distribution pattern: Kansas and Missouri
Derived failure modes
-
Sterility assurance
Lack of sterility