D-0826-2018 Class II Terminated
FDA drug recall D-0826-2018 was initiated by Exela Pharma Sciences LLC on April 20, 2018 and is designated Class II. Reason for recall: Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. The recall status is terminated (terminated June 4, 2020). Affected quantity: 5256 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- April 20, 2018
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5256 bottles
Product Description
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
Reason for Recall
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot: GH70154, Exp 12/18