Class II
Terminated
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.
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- April 20, 2018
- Posted
- May 30, 2018
- Recall Number
- D-0826-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5256 bottles
- Firm Location
- Lenoir, NC, United States
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
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot: GH70154, Exp 12/18
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