Drug product
Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
D-0056-2015
Product summary
- Event
- Event 69152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 mL
- Official record key
drug-enforcement:D-0056-2015
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: 07092014@21, Exp 10/7/2014; 08082014@40, Exp 11/6/2014
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility