Why it was recalled
Presence of Foreign Substance
Product description
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
Lot numbers, UPCs & expiration codes
Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023
Where it was sold
Nationwide with the United States
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-0024-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 18, 2022
- FDA report date
- Nov 9, 2022
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0024-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91033
- Address
- 2 Independence Way
- Code information
- Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023
- Postal code
- 08540-6620
- Report date
- Nov 9, 2022
- Product type
- Drugs
- Recall number
- D-0024-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Termination date
- Sep 7, 2023
- Reason for recall
- Presence of Foreign Substance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Oct 18, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 31, 2022