Class II · Moderate riskTerminated Initiated Feb 26, 2021 (6 years ago)
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
What was recalled
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.
Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
43598-350-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0292-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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