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Recall Observatory FDA recall evidence

Drug product

Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085

D-1186-2022

June 10, 2022

Class II

Product summary

Firm
Wedgewood Village Pharmacy, LLC
Event
Event 90403
Status
Terminated
Classification
Class II
Quantity
9/18/2022
Official record key
drug-enforcement:D-1186-2022

Official wording

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Code information: Lot#: 000-03866709 Exp Date: 09/18/22

Distribution pattern: Products were distributed nationwide in the USA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls