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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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