Pallimed Recalls Buprenorphine Veterinary Injection Due to Sterility Concerns
Pallimed Solutions is recalling 71 vials of Buprenorphine HCl Veterinary Injection nationwide due to FDA inspectional findings regarding sterility assurance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant quality defects like sterility assurance issues in injectable products are categorized as Severe.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling 71 vials of Buprenorphine HCl Veterinary Injection. The product was distributed nationwide. The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility.
The recall covers all lots within the expiry date. The specific hazard identified is a lack of assurance of sterility, which is a critical quality attribute for injectable veterinary medications.
Veterinarians and veterinary clinics that received this product should stop using it and contact Pallimed Solutions for instructions on how to return the product. Consumers should not use this veterinary medication for human purposes.
The recalled product
- Product
- Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Veterinary Injection
- Hazard
- Affected units
- 71
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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 25 products in this recall →Related recalls
Same manufacturer · Pallimed Solutions
See all →- SeverePallimed Solutions Recalls Atropine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-08-21
- SeverePallimed Solutions Recalls Trimix Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-08-21
- SevereQuadmix Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-08-21
- SeverePallimed Acetylcysteine Ophthalmic Solution Recalled for Sterility Concerns
FDA (Drugs) · 2013-08-21
- SeverePallimed Solutions Recalls Testosterone Injection Due to Sterility Concerns
FDA (Drugs) · 2013-08-21
Same hazard · sterility concern
See all →- HighSegmental Stem Components for ELEOS Limb Salvage System Recalled
FDA (Devices) · 2025-06-04
- HighMEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
FDA (Devices) · 2024-10-16
- HighProparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-10-02
- HighExactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
FDA (Devices) · 2024-06-26
- HighPantoprazole Sodium for Injection Recalled Due to Sterility Concern
FDA (Drugs) · 2023-09-20
Similar recalls
- SevereGreen Valley Drugs Recalls Buprenorphine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- HighBuprenorphine Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-02-01
- SeverePharmedium Recalls Bupivacaine HCl Injection Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- SeverePharmedium Recalls Fentanyl and Bupivacaine Injections Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- SeverePharmedium Recalls Ropivacaine HCl Injection Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- ModerateBuprenorphine HCl Injection Recalled for Crystallization Defect
FDA (Drugs) · 2023-11-15