D-1028-2013 Class II Terminated
FDA drug recall D-1028-2013 was initiated by Pharmacy Creations on August 26, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 25, 2016). Affected quantity: 50 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2013
- Initiation Date
- August 26, 2013
- Termination Date
- April 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 vials
Product Description
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Reason for Recall
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.
Distribution Pattern
NJ
Code Information
Lot # 214490.00, Exp 11/29/2013