Status
Terminated
Drug Enforcement D-869-2013
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Classification
Class II
Report Date
August 21, 2013
Termination Date
August 21, 2013
Product Information
- Product description
- HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Product quantity
- 261 vials
- Reason for recall
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Pallimed Solutions
- Address
-
400 W Cummings Park
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-869-2013
- Event ID
- 64716
- Recall initiation date
- March 25, 2013
- Center classification date
- August 9, 2013
- Code info
- All lots within expiry
- More code info
- —