Status
Terminated
Drug Enforcement D-446-2014
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Classification
Class II
Report Date
January 22, 2014
Termination Date
September 22, 2014
Product Information
- Product description
- Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Product quantity
- 180 mL
- Reason for recall
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Hospitals, clinics, physicians, and patients in the Michigan area only.
Location & Firm
- Recalling firm
- Specialty Medicine Compounding Pharmacy
- Address
-
350 S Lafayette St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-446-2014
- Event ID
- 66566
- Recall initiation date
- October 19, 2013
- Center classification date
- January 10, 2014
- Code info
- All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10022013@6, 10162013@3, t10172013@10
- More code info
- —