Why it was recalled
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Product description
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
Lot numbers, UPCs & expiration codes
Lot # 17220002, Exp Date 11/30/2023
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-0112-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 23, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0112-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93262
- Address
- 750 Corporate Dr
- Code information
- Lot # 17220002, Exp Date 11/30/2023
- Postal code
- 07430-2009
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0112-2024
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Termination date
- Jul 5, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2023