D-0995-2019 Class III Terminated
FDA drug recall D-0995-2019 was initiated by Dr. Reddy's Laboratories, Inc. on February 6, 2019 and is designated Class III. Reason for recall: Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. The recall status is terminated (terminated January 26, 2021). Affected quantity: 40,592, 90 and 1,000 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- February 6, 2019
- Termination Date
- January 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,592, 90 and 1,000 count bottles
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.
Reason for Recall
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.