FDA recall D-0924-2017

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.

Reason for recall

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-06-05

Report date

2017-07-05

Termination date

2017-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portland, ME, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0924-2017