Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
National Drug Code
Is NDC 0409-2012-32 recalled?
Buprenorphine Hydrochloride · 10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03)
Yes — this exact package was recalled
1 FDA recall names the code 0409-2012-32 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.
1 of these recalls is still ongoing.
- Active ingredient
- Buprenorphine Hydrochloride
- Strength
- BUPRENORPHINE HYDROCHLORIDE .3 mg/mL
- Form
- Injection, Solution · Intramuscular, Intravenous
- Labeler
- Hospira, Inc.
- Type
- Human Prescription Drug · DEA CIII
- Product code
- 0409-2012
Recalls naming this package
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
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
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