D-0292-2021 Class II Terminated
FDA drug recall D-0292-2021 was initiated by Dr. Reddy's Laboratories, Inc. on February 26, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing. The recall status is terminated (terminated February 17, 2022). Affected quantity: 16,449 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 10, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- February 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,449 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch # 1399851P1, Exp 02/2021