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Recall Observatory FDA recall evidence

Drug product

Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

D-0353-2016

October 16, 2015

Class II

Product summary

Firm
Downing Labs, LLC
Event
Event 72455
Status
Terminated
Classification
Class II
Quantity
2189 vials
Official record key
drug-enforcement:D-0353-2016

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