February 2021 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-0292-2021 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on February 26, 2021 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0292-2021
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
02-26-2021
03-10-2021
16,449 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
02-17-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Batch# 1399851P1, Exp 02/2021
