FDA recall D-1426-2014

Product

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

Reason for recall

Discoloration; due to prolonged heat exposure.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2013-09-19

Report date

2014-07-16

Termination date

2015-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1426-2014