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Recall Observatory FDA recall evidence

Drug product

Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085

D-1184-2022

June 10, 2022

Class II

Product summary

Firm
Wedgewood Village Pharmacy, LLC
Event
Event 90403
Status
Terminated
Classification
Class II
Quantity
14 suppositories
Official record key
drug-enforcement:D-1184-2022

Official wording

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

Code information: Lot#: 000-03843532 Exp Date: 09/6/22

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