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Recall Observatory FDA recall evidence

Drug product

Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Dr, Ste 200, Swedesboro, NJ 08085

D-1182-2022

June 10, 2022

Class II

Product summary

Firm
Wedgewood Village Pharmacy, LLC
Event
Event 90403
Status
Terminated
Classification
Class II
Quantity
24 bottles
Official record key
drug-enforcement:D-1182-2022

Official wording

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

Code information: Lot#: 000-03852523, Exp Date: 09/01/22; Lot#: 000-03766625, Exp Date:07/10/22; Lot#: 000-03780127, Exp Date: 08/6/22; Lot#: 000-03794760, Exp Date: 08/6/22; Lot#: 000-03892723, Exp Date: 09/1/22; Lot#: 000-03641022, Exp Date: 06/17/22; Lot#: 000-03693714, Exp Date: 06/28/22; Lot#: 000-03770510, Exp Date: 08/6/22; Lot#: 000-03852462, Exp Date: 09/1/22; Lot#: 000-03840601, Exp Date: 09/1/22; Lot#: 000-03706934, Exp Date: 06/28/22; Lot#: 000-03850609, Exp Date: 09/1/22; Lot#: 000-03650269, Exp Date: 06/17/22; Lot#: 000-03870004, Exp Date: 09/1/22; Lot#: 000-03693748, Exp Date: 06/28/22; Lot#: 000-03904403, Exp Date: 09/1/22; Lot#: 000-03799564, Exp Date: 08/06/22; Lot#: 000-03723022, Exp Date: 06/28/22; Lot#: 000-03872892, Exp Date: 09/01/22; Lot#: 000-03885204, Exp Date: 09/01/22; Lot#: 000-03848586, Exp Date: 09/01/22; Lot#: 000-03903599, Exp Date: 09/01/22; Lot#: 000-03812001, Exp Date: 08/06/22;

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