Pfizer recalls Buprenorphine Hydrochloride Injection (0.3 mg/mL) due to potential contamination from incomplete crimp seals. This affects specific lots manufactured by Hospira. No remedy is stated in the recall notice.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer is recalling a specific type of Buprenorphine injection due to a risk of contamination from incomplete crimp seals. This could lead to infections if the product is used improperly. The recall affects certain lots with specific expiration dates.
The product may have incomplete crimp seals, which could allow contamination during storage or use. This increases the risk of infection if the injection is administered improperly.
Patients prescribed this medication by a healthcare provider. Those using the product without proper medical supervision are at higher risk.
Check the product label for the NDC code 0409-2012-03 and lot numbers HJ3965 (expiring 2024/09) or HJ8546 (expiring 2024/10). The product is a single-dose sterile cartridge for intramuscular or intravenous use.
Look for the NDC code 0409-2012-03 and lot numbers HJ3965 (expiring 2024/09) or HJ8546 (expiring 2024/10) on the packaging.
The recall states there is a potential risk of contamination from incomplete crimp seals, but no specific remedy is provided. The product may be safe if handled properly, but the manufacturer recommends checking the recall details.
The recall notice does not specify any action steps. You should check the product label for the NDC code and lot numbers to determine if it is affected.
Check the product label for the NDC code 0409-2012-03 and lot numbers HJ3965 (expiring 2024/09) or HJ8546 (expiring 2024/10).
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0564-2024 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0564-2024 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
