Recalls / Class II
Class IID-0069-2015
Product
Chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Affected lot / code info
- Lot Number: 03182014@24, Exp 9/14/2014; 04012014@31, Exp 9/28/2014; 06032014@30, Exp 11/30/2014; 07292014@28, Exp 1/25/2015
Why it was 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.
Recalling firm
- Firm
- Martin Avenue Pharmacy, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1247 Rickert Dr, N/A, Naperville, Illinois 60540-1008
Distribution
- Quantity
- 500 mL
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-27
- FDA classified
- 2014-10-29
- Posted by FDA
- 2014-11-05
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0069-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.