FDA-Drug2021-03-10Class II

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.

Dr. Reddy's Laboratories, Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
16,449 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
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.

Official notice

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

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