PlainRecalls
FDA Drug Moderate Class II Terminated

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

Reported: June 14, 2023 Initiated: May 3, 2023 #D-0869-2023

Product Description

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

Reason for Recall

CGMP Deviations

Details

Units Affected
12,336 bottles
Distribution
Product was distributed to 19 distributors nationwide.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 12,336 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on June 14, 2023. Severity: Moderate. Recall number: D-0869-2023.