Buprenorphine Sublingual Tablets recall: CGMP Deviations
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Why was Buprenorphine Sublingual Tablets recalled?
CGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: DND1515A, Exp 08/24
- Product
- Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 12,336 bottles
- Distribution
- Product was distributed to 19 distributors nationwide.
- Recall date
- June 14, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)