Drug product
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869
D-1029-2013
Product summary
- Event
- Event 66100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 vials
- Official record key
drug-enforcement:D-1029-2013
Official wording
Reason: Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Code information: Lot # 070213Z, Exp 1/2/2014
Distribution pattern: NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility