PlainRecalls
FDA Drug Moderate Class II Terminated

Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Reported: November 5, 2014 Initiated: August 27, 2014 #D-0070-2015

Product Description

Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Reason for Recall

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.

Details

Units Affected
22.89055 gm
Distribution
Nationwide
Location
Naperville, IL

Frequently Asked Questions

What product was recalled?
Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.. Recalled by Martin Avenue Pharmacy, Inc.. Units affected: 22.89055 gm.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 5, 2014. Severity: Moderate. Recall number: D-0070-2015.