Par Sterile Products recalls buprenorphine injections that may crystallize, causing potential safety issues. This recall affects specific lots manufactured between 2021 and 2023.
Crystallization; identified as Buprenorphine free base
Par Sterile Products is recalling buprenorphine injections that could crystallize, which might lead to safety concerns. This recall affects specific lots with expiration dates from November 2021 to February 2023.
The buprenorphine injections may crystallize, which could potentially cause safety issues during administration. This crystallization is identified as buprenorphine free base.
Prescription patients using buprenorphine injections for pain management. Healthcare providers who dispensed these injections are also affected.
Check for the product name 'Buprenorphine HCl, Injection, 0.3mg/mL' in packages of 5 vials. Look for lot numbers 343716 (exp. 11/2021), 350565 (exp. 07/2022), 26921 (exp. 07/2022), or 36227 (exp. 02/2023).
Identify the lot number and expiration date on the vial packaging to determine if it is part of the recalled lots.
The buprenorphine injections may crystallize, which is identified as buprenorphine free base. This could potentially cause safety issues during administration.
The official recall notice does not specify a remedy for this product. Check the product details to see if it is part of the recalled lots.
Lots 343716 (exp. 11/2021), 350565 (exp. 07/2022), 26921 (exp. 07/2022), and 36227 (exp. 02/2023).
We’ve drafted a message you can send Par Sterile Products to request your refund or repair — edit it as you like.
Subject: Recall D-0087-2024 — Par Sterile Products Par Sterile Products Hello, I own a Par Sterile Products that is covered by recall D-0087-2024 from Par Sterile Products. 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.
