Drug recall D-0737-2022
Product
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
Reason for recall
Failed Dissolution Specifications; during long term stability testing.
Lots and codes
Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 8,352 bottles (30-count), 1,368 bottles (90-count)
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 23, 2022
- Terminated
- February 2, 2024
Related products
- Lansoprazole – drug information
- NDC 55111-398 Lansoprazole · Lansoprazole 15 mg/1 · Dr.Reddy's Laboratories Ltd.
- NDC 55111-399 Lansoprazole · Lansoprazole 30 mg/1 · Dr.Reddy's Laboratories Ltd.