Recall: D-0869-2023

Class II - Potentially Harmful

Class IIClassification

2023-05-03Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

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

Reason

CGMP Deviations

Distribution

Product was distributed to 19 distributors nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.