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.

FDA recall notice · announced March 10, 2021 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Batch # 1399851P1, Exp 02/2021
Quantity: 16,449 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0292-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.