D-0004-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 12, 2016
- Initiation Date
- September 12, 2016
- Termination Date
- January 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 247.5 mL total volume
Product Description
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Reason for Recall
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Distribution Pattern
Oklahoma
Code Information
07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016