PAR Sterile Products Recalls Buprenorphine Hydrochloride Injection Due to Crystallization
PAR Sterile Products LLC is recalling Buprenorphine Hydrochloride Injection due to the presence of white, crystalline particulates in the vials.
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: The recall is classified as FDA Class II, and the hazard involves physical particulates (crystallization) rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity recall.
Plain-English summary
PAR Sterile Products LLC is voluntarily recalling 122,469 cartons of Buprenorphine Hydrochloride Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01). The recall was initiated because of the presence of white, crystalline particulates adhered to the side and bottom of the glass vials. These particulates are comprised principally of dextrose and the buprenorphine active component.
The affected product is distributed nationwide in the USA. The recall includes specific lots with expiration dates ranging from January 2018 to October 2018. The product is a prescription-only medication intended for intramuscular or intravenous administration.
Consumers and healthcare providers should discontinue use of the affected lots and return them to the pharmacy or point of purchase for a refund. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- PAR Sterile Products LLC
- Category
- Drug — Injection
- Affected units
- 122,469
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 (19)
- Lot #: 821102
- 821103
- Exp 01/18
- 821104
- 821106
- 821107
- Exp 02/18
- 821108
- Exp 03/18
- 821884
- 821885
- Exp 07/18
- 821886
- 821887
- Exp 08/18
- 822767
- Exp 09/18
- 824183
- Exp 10/18.
Distribution
Distributed nationwide across the United States.
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