Recalls / Class II
Class IID-0024-2023
Product
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
- Brand name
- Buprenorphine And Naloxone
- Generic name
- Buprenorphine And Naloxone
- Active ingredients
- Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate
- Route
- Sublingual
- NDCs
- 62756-969, 62756-970
- FDA application
- ANDA201633
- Affected lot / code info
- Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023
Why it was recalled
Presence of Foreign Substance
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide with the United States
Timeline
- Recall initiated
- 2022-10-18
- FDA classified
- 2022-10-31
- Posted by FDA
- 2022-11-09
- Terminated
- 2023-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0024-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.