Skip to content
Recall Observatory FDA recall evidence

Drug product

DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

D-0359-2016

October 16, 2015

Class II

Product summary

Firm
Downing Labs, LLC
Event
Event 72455
Status
Terminated
Classification
Class II
Quantity
475 vials
Official record key
drug-enforcement:D-0359-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots

Distribution pattern: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility