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Recall Observatory FDA recall evidence

Drug product

Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

D-1206-2020

April 06, 2020

Class II

Product summary

Firm
The Medicine Shoppe Pharmacy
Event
Event 85404
Status
Terminated
Classification
Class II
Quantity
1 bottle
Official record key
drug-enforcement:D-1206-2020

Official wording

Reason: Lack of Processing Control

Code information: Lot: 45163 Discard by: 9/1/2020

Distribution pattern: Florida

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Control