D-1256-2020 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

FDA drug recall D-1256-2020 was initiated by Dr. Reddy's Laboratories, Inc. on April 24, 2020 and is designated Class III. Reason for recall: Discoloration: product contains brown pellets The recall status is terminated (terminated May 13, 2022). Affected quantity: 1752 bottles.

Recall Details

Product Type
Drugs
Report Date
May 6, 2020
Initiation Date
April 24, 2020
Termination Date
May 13, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1752 bottles

Product Description

Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

Reason for Recall

Discoloration: product contains brown pellets

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: C900642, Exp. 06/2020