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Recall Observatory FDA recall evidence

Drug product

Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03

D-0152-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
945 syringes
Official record key
drug-enforcement:D-0152-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 07272018:17 Discard by: 9/25/2018; 08292018:74 Discard by: 10/28/2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility