Recalls / Class III
Class IIID-0995-2019
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.
- 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 #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
Why it was recalled
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain 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
- 40,592, 90 and 1,000 count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2019-02-06
- FDA classified
- 2019-03-12
- Posted by FDA
- 2019-02-20
- Terminated
- 2021-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0995-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.