Drug product
Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
D-0070-2015
Product summary
- Event
- Event 69152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22.89055 gm
- Official record key
drug-enforcement:D-0070-2015
Official wording
Reason: Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Code information: Lot Number: 03222014@5, Exp 9/18/2014; 04042014@9, Exp 10/1/2014; 05162014@15, Exp 11/12/2014; 07242014@18, Exp 1/20/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility