PlainRecordsFDA · Drug recall
Buprenorphine Sublingual Tablets…
- Date
- June 14, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries Inc
- Product
- Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
- Reason
- CGMP Deviations
- Distribution pattern
- Product was distributed to 19 distributors nationwide.
- Quantity
- 12,336 bottles
- Codes and lots
- Lot #: DND1515A, Exp 08/24
- Recall started
- May 3, 2023
- Recall number
- D-0869-2023
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0869-2023. The agency record governs; check it and the company before acting.