FDA-Drug2023-06-14Class II

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

CGMP Deviations

Sold states
Product was distributed to 19 distributors nationwide.
Affected count
12,336 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2023

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