Skip to content
Recall Observatory FDA recall evidence

Drug product

Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.

D-0924-2017

June 05, 2017

Class II

Product summary

Firm
Apothecary By Design
Event
Event 77615
Status
Terminated
Classification
Class II
Quantity
25 vials
Official record key
drug-enforcement:D-0924-2017

Official wording

Reason: Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.

Code information: Lot #: 04192017@1, Exp 09/30/2017

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls