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Recall Observatory FDA recall evidence

Drug product

All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

D-1077-2016

March 25, 2016

Class II

Product summary

Firm
Reliable Rexall-A Compounding Pharmacy
Event
Event 73662
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1077-2016

Official wording

Reason: Lack of Processing Controls

Code information: All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Distribution pattern: U.S. Including: CA, HI, NM

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls