Drug recall D-0292-2021

Class II Terminated reported Mar 10, 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.

Lots and codes

Batch # 1399851P1, Exp 02/2021

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
16,449 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 26, 2021
Terminated
February 17, 2022

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