Recalls / Class II
Class IID-0826-2018
Product
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.
- Affected lot / code info
- Lot: GH70154, Exp 12/18
Why it was recalled
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.
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 5256 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-04-20
- FDA classified
- 2018-05-22
- Posted by FDA
- 2018-05-30
- Terminated
- 2020-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0826-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.