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.
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.
Lot numbers, UPCs & expiration codes
Lot: GH70154, Exp 12/18
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0826-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 20, 2018
- FDA report date
- May 30, 2018
- Quantity
- 5256 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Exela Pharma Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0826-2018, exactly as published.
Show all FDA fields
- City
- Lenoir
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 79969
- Address
- 1245 Blowing Rock Blvd
- Code information
- Lot: GH70154, Exp 12/18
- Postal code
- 28645-3618
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0826-2018
- Classification
- Class II
- Recalling firm
- Exela Pharma Sciences LLC
- Product quantity
- 5256 bottles
- Termination date
- Jun 4, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Apr 20, 2018
- Initial firm notification
- Letter
- Center classification date
- May 22, 2018