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.
Reported: March 10, 2021 Initiated: February 26, 2021 #D-0292-2021
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 16,449 bottles
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product 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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 16,449 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 10, 2021. Severity: Moderate. Recall number: D-0292-2021.
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