D-0036-2025 Class II Ongoing
FDA drug recall D-0036-2025 was initiated by Dr. Reddy's Laboratories, Inc. on October 22, 2024 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specification The recall status is ongoing. Affected quantity: 2,040 100-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2024
- Initiation Date
- October 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,040 100-count bottles
Product Description
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Reason for Recall
Failed Impurities/Degradation Specification
Distribution Pattern
Nationwide in the USA
Code Information
Lot# FG14062, Exp 10/31/2025