Recalls / Class II
Class IID-0292-2021
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.
- Brand name
- Progesterone
- Generic name
- Progesterone
- Active ingredient
- Progesterone
- Route
- Oral
- NDCs
- 43598-349, 43598-350
- FDA application
- ANDA208801
- Affected lot / code info
- Batch # 1399851P1, Exp 02/2021
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 16,449 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-02-26
- FDA classified
- 2021-03-03
- Posted by FDA
- 2021-03-10
- Terminated
- 2022-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0292-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.