Buprenorphine and Naloxone Sublingual Tablets Recalled for Foreign Substance
Sun Pharmaceutical is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) due to a foreign substance. Affected lots DNC1129A and DNC1740A were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a prescription medication due to a foreign substance. The recall represents a risk-of-harm scenario (risk-of-harm products where injury has not yet been reported), warranting a High (3) severity score per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) distributed nationwide in the United States. The affected lots are DNC1129A (expiration date 06/2023) and DNC1740A (expiration date 09/2023).
The recall was issued because of the presence of a foreign substance in the tablets. The tablets are prescription medications used for opioid addiction treatment.
Consumers who have this medication from the affected lots can contact their pharmacist or healthcare provider. Healthcare providers and pharmacists can use the lot numbers listed to verify whether their stock is affected.
The recalled product
- Product
- BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
- Brand
- BUPRENORPHINE AND NALOXONE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Sublingual Tablet
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: DNC1129A
- Exp 06/2023 Lot #: DNC1740A
- Exp 09/2023
UPCs (1)
- 0362756969834
Distribution
Distributed nationwide across the United States.
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