Buprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue
Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No reported illnesses or injuries, but incomplete seals in injectable medication create a risk-of-harm scenario fitting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pfizer Inc., through its distributor Hospira, is recalling 84,710 cartridges of Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Carpuject units, following discovery of a manufacturing quality issue. The product is distributed nationwide in the United States and Puerto Rico.
The recall is due to potential incomplete crimp seals on the cartridge units. These seals are critical to maintaining the sterility of the injectable medication. Incomplete or compromised seals could allow the product to become contaminated during storage or handling.
This is a Class II recall. No illnesses or injuries related to this issue have been reported to date. However, patients who have received injections from the affected lots should contact their healthcare provider to discuss any potential concerns.
Patients should not use affected products from Lot HJ3965 (expiration 2024/09) or Lot HJ8546 (expiration 2024/10). Healthcare providers and patients with questions about this recall should contact Pfizer or consult their pharmacist for guidance on obtaining replacement medication.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable / Injection
- Affected units
- 84,710
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 (3)
- Lot#: HJ3965
- Exp 2024/09 Lot#: HJ8546
- Exp 2024/10
Distribution
Part of a larger recall action
This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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