D-861-2013 Class II Terminated
FDA drug recall D-861-2013 was initiated by Pallimed Solutions on March 25, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance The recall status is terminated (terminated August 21, 2013). Affected quantity: 246 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2013
- Initiation Date
- March 25, 2013
- Termination Date
- August 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246 vials
Product Description
BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Reason for Recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Distribution Pattern
Nationwide
Code Information
All lots within expiry