Drug product
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05
D-0242-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 vials
- Official record key
drug-enforcement:D-0242-2016
Official wording
Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Code information: Lot Numbers: 20152303@7 BUD: 9/19/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility