Class II ยท Moderate risk
Belbuca (buprenorphine hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
National Drug Code
Is NDC 59385-0023-60 recalled?
Belbuca · 60 POUCH in 1 CARTON (59385-023-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-023-01)
Yes — this exact package was recalled
1 FDA recall names the code 59385-0023-60 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- buprenorphine hydrochloride
- Strength
- BUPRENORPHINE HYDROCHLORIDE 300 ug/1
- Form
- Film, Soluble · Buccal
- Labeler
- BioDelivery Sciences International Inc
- Type
- Human Prescription Drug · DEA CIII
- Product code
- 59385-0023
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 59385-0025 Belbuca 1
- 59385-0041 Symproic 1
Free recall alerts
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