Buprenorphine Hydrochloride Injection recall
FDA recall D-0564-2024 · initiated May 20, 2024
Pfizer Inc. recalled Buprenorphine Hydrochloride Injection in May 2024 — an FDA Class II recall (D-0564-2024) because Lack of Assurance of Sterility-The potential for incomplete crimp seals.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 84,710 cartridges
Details
- Product
- Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03
- Recalling company
- Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide and Puerto Rico.
- Initiated
- May 20, 2024
- FDA report date
- Jul 3, 2024
Frequently asked
- Was Buprenorphine Hydrochloride Injection recalled?
- Pfizer Inc. recalled Buprenorphine Hydrochloride Injection in May 2024 — an FDA Class II recall (D-0564-2024) because Lack of Assurance of Sterility-The potential for incomplete crimp seals. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Buprenorphine Hydrochloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0564-2024 was: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- Is a recalled Buprenorphine Hydrochloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Buprenorphine Hydrochloride Injection are affected?
- Distributed: US Nationwide and Puerto Rico.. The recall covers these lots — Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0564-2024.