Drug product
"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
D-0107-2015
Product summary
- Event
- Event 69152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 mL
- Official record key
drug-enforcement:D-0107-2015
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: 07152014@52, Exp 9/30/2014; 07202014@7, Exp 10/18/2014
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility