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FDAFDA · Food and drugs·Recall number D-0869-2023

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

Published June 14, 2023 · Recall initiated: May 3, 2023

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
BUPRENORPHINE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Distributor
Product was distributed to 19 distributors nationwide.
Lot
Lot #: DND1515A, Exp 08/24
Risk classification
Class II
Area (FDA)
drug
Country
United States

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