Drug product
Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
D-0123-2015
Product summary
- Event
- Event 69152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 mL
- Official record key
drug-enforcement:D-0123-2015
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: 08112014@24, Exp 11/9/2014
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility