Why it was recalled
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Product description
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
Lot numbers, UPCs & expiration codes
Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
Where it was sold
Distributed 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-0995-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 6, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 40,592, 90 and 1,000 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0995-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82065
- Address
- 107 College Rd E
- Code information
- Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
- Postal code
- 08540-6623
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0995-2019
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 40,592, 90 and 1,000 count bottles
- Termination date
- Jan 26, 2021
- Reason for recall
- Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Feb 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2019