Buprenorphine HCl Injection Recalled for Crystallization Defect
Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall addresses a pharmaceutical quality defect discovered during routine inspection. The source identifies only the crystallization issue with no adverse events mentioned. The recall is precautionary based on product quality findings in stored samples.
Plain-English summary
PAR Sterile Products LLC is recalling Buprenorphine Hydrochloride (HCl) 0.3mg/mL Injection, 1mL Single Dose Vials (supplied in packages of 5 vials) distributed nationwide. The recall was initiated after white crystalline product agglomeration was observed in 2 vials during an annual inspection of retain samples.
Affected lot numbers include 343716 (expiration 11/2021), 350565 (07/2022), 26921 (07/2022), and 36227 (02/2023). The product is identified by National Drug Code (NDC) 42023-179-05 and was distributed by Par Pharmaceutical located in Chestnut Ridge, New York.
Crystallization in injectable pharmaceutical products can affect drug quality and efficacy. Patients or healthcare providers who have questions about this product should contact PAR Sterile Products LLC or consult their healthcare provider.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- PAR Sterile Products LLC
- Category
- Drug — Injectable
- Hazard
- crystallization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot No: 343716
- Exp. Date: 11/2021
- Lot No: 350565
- Exp. Date: 07/2022
- Lot No: 26921
- Lot No: 36227
- Exp. Date: 02/2023
Distribution
Distributed nationwide across the United States.
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