Drug 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.
D-0292-2021
Product summary
- Event
- Event 87411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,449 bottles
- Official record key
drug-enforcement:D-0292-2021
Official wording
Reason: Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Code information: Batch # 1399851P1, Exp 02/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification