Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
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.
Lot numbers, UPCs & expiration codes
Batch # 1399851P1, Exp 02/2021
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0292-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2021
- FDA report date
- Mar 10, 2021
- Quantity
- 16,449 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0292-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87411
- Address
- 107 College Rd E
- Code information
- Batch # 1399851P1, Exp 02/2021
- Postal code
- 08540-6623
- Report date
- Mar 10, 2021
- Product type
- Drugs
- Recall number
- D-0292-2021
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 16,449 bottles
- Termination date
- Feb 17, 2022
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 26, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2021