D-0160-2016 Class II Terminated
FDA drug recall D-0160-2016 was initiated by Chen Shwezin, Inc. dba Park Compounding Pharmacy on October 6, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: all sterile compounded products within expiry The recall status is terminated (terminated November 27, 2015). Affected quantity: 2 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- November 4, 2015
- Initiation Date
- October 6, 2015
- Termination Date
- November 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 vials
Product Description
TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
Reason for Recall
Lack of Assurance of Sterility: all sterile compounded products within expiry
Distribution Pattern
CA
Code Information
Lot# 09162015@4, Exp, 10/16/15