Skip to content
Recall Observatory FDA recall evidence

Drug product

PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258

D-0156-2016

October 06, 2015

Class II

Product summary

Firm
Chen Shwezin, Inc. dba Park Compounding Pharmacy
Event
Event 72402
Status
Terminated
Classification
Class II
Quantity
2 vials
Official record key
drug-enforcement:D-0156-2016

Official wording

Reason: Lack of Assurance of Sterility: all sterile compounded products within expiry

Code information: Lot#: 09082015@36, Exp 10/8/15

Distribution pattern: CA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility