Drug product
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
D-0270-2015
Product summary
- Firm
- Perry Drug Inc.
- Event
- Event 69674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0270-2015
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: 141016A, 11/16/14
Distribution pattern: Kansas and Missouri
Derived failure modes
-
Sterility assurance
Lack of sterility