Why it was recalled
CGMP Deviations
Product description
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Lot numbers, UPCs & expiration codes
Lot #: DND1515A, Exp 08/24
Where it was sold
Product was distributed to 19 distributors nationwide.
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-0869-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 3, 2023
- FDA report date
- Jun 14, 2023
- Quantity
- 12,336 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0869-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92256
- Address
- 2 Independence Way
- Code information
- Lot #: DND1515A, Exp 08/24
- Postal code
- 08540-6620
- Report date
- Jun 14, 2023
- Product type
- Drugs
- Recall number
- D-0869-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 12,336 bottles
- Termination date
- Jan 9, 2024
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
- Distribution pattern
- Product was distributed to 19 distributors nationwide.
- Recall initiation date
- May 3, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2023