Drug product
Bacteriostatic water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
D-0062-2015
Product summary
- Event
- Event 69152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 mL
- Official record key
drug-enforcement:D-0062-2015
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: 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
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility