Recalls / Class III
Class IIID-1256-2020
Product
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
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Active ingredient
- Esomeprazole Magnesium
- Route
- Oral
- NDCs
- 43598-509, 43598-510
- FDA application
- ANDA078279
- Affected lot / code info
- Lot #: C900642, Exp. 06/2020
Why it was recalled
Discoloration: product contains brown pellets
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 1752 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-04-24
- FDA classified
- 2020-04-28
- Posted by FDA
- 2020-05-06
- Terminated
- 2022-05-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1256-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.