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Recall Observatory FDA recall evidence

Drug product

HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

D-0436-2017

October 18, 2016

Class III

Product summary

Firm
Town and Country Compounding and Consultation Services, LLC
Event
Event 75700
Status
Terminated
Classification
Class III
Quantity
101 vials
Official record key
drug-enforcement:D-0436-2017

Official wording

Reason: Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

Code information: Lot #: 05272016@17

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent