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Recall Observatory FDA recall evidence

Drug product

Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01

D-0420-2019

December 17, 2018

Class II

Product summary

Firm
Duren Health Mart Pharmacy
Event
Event 81811
Status
Terminated
Classification
Class II
Quantity
1306 capsules
Official record key
drug-enforcement:D-0420-2019

Official wording

Reason: Lack of Processing Controls.

Code information: N/A

Distribution pattern: TN only

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls