NDC 21695-515
Buprenorphine Hydrochloride 0.3 mg per 1 mL injection, solution
On the label: Rebel Distributors Corp... It's repackaged: Rebel Distributors Corp.. rebottles it from Hospira, Inc.'s NDC 0409-2012.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | McPherson, KS, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
| Macfarlan Smith Limited | Edinburgh, United Kingdom | Makes the active ingredient | Problems found, fixed voluntarilyNov 29, 2021 · 4 inspections |
Recalls
- May 20, 2024 · Class II · Pfizer Inc.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lots: Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10 - Sep 9, 2014 · Class II · Hospira Inc.
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Lots: Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Buprenorphine: every company that makes it
- Form
- injection, solution
- Strength
- 0.3 mg per 1 mL
- Approval
- ANDA ANDA074137
- On the market since
- Jul 12, 2010
- Package NDCs
21695-515-10- Official label
- DailyMed (National Library of Medicine), updated Dec 10, 2010
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