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Recall Observatory FDA recall evidence

Drug product

Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

D-1327-2019

May 23, 2019

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 82941
Status
Terminated
Classification
Class II
Quantity
11 vials
Official record key
drug-enforcement:D-1327-2019

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 05022019:50 Exp. 10/29/2019; 05082019:91 Exp. 06/08/2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility