Recall: D-0995-2019

Class III - Minor Violations

Class IIIClassification

2019-02-06Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

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

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.