FDA recall D-0292-2021

Product

Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.

Reason for recall

Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-02-26

Report date

2021-03-10

Termination date

2022-02-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2021