Buprenorphine Sublingual Tablets Recalled for Manufacturing Quality Deviations
Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II voluntary precautionary recall. The rubric identifies voluntary precautionary recalls as Moderate severity. No illnesses, injuries, or adverse events are documented in the source.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 12,336 bottles of Buprenorphine 8 mg sublingual tablets due to Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. The affected lot is DND1515A with an expiration date of August 2024. Buprenorphine is a prescription opioid medication used to treat opioid use disorder.
The CGMP deviations were identified by the manufacturer, which voluntarily initiated this recall on May 3, 2023. The product was distributed to 19 distributors across the United States. The recall was terminated on January 9, 2024.
Patients currently taking buprenorphine should verify their medication lot number and contact their healthcare provider or pharmacist if they possess the recalled lot. Healthcare providers and dispensing pharmacies should verify whether their patients or inventory includes the recalled lot DND1515A and provide appropriate guidance to affected patients.
The recalled product
- Product
- BUPRENORPHINE (BUPRENORPHINE)
- Brand
- BUPRENORPHINE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Opioid
- Hazard
- Affected units
- 12,336
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 (2)
- Lot #: DND1515A
- Exp 08/24
Distribution
Distributed nationwide across the United States.
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