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
Product summary
- 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
Lack of Processing Controls