Skip to content
Recall Observatory FDA recall evidence

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

August 27, 2014

Class II

Product summary

Firm
Martin Avenue Pharmacy, Inc.
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility