Recalls / Class II
Class IID-0062-2015
Product
Bacteriostatic water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Affected lot / code info
- Lot Number: 03082014@2, Exp 9/4/2014; 04142014@8, Exp 10/11/2014; 05242014@2, Exp 11/20/2014; 06202014@20, Exp 12/17/2014; 08192014@33, Exp 2/15/2015
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
- 600 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-0062-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.