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Recall Observatory FDA recall evidence

Drug product

Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding

D-1229-2022

March 07, 2022

Class II

Product summary

Firm
TMC Acquisition LLC dba Tailor Made Compounding
Event
Event 89909
Status
Ongoing
Classification
Class II
Quantity
12 syringes
Official record key
drug-enforcement:D-1229-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Batch#: 01132208A1, Exp 4/13/2022; 02252205A1, Exp 5/26/2022.

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility