Beacon Hill Medical Pharmacy Recalls Compounded Buprenorphine Cream
Beacon Hill Medical Pharmacy is recalling compounded buprenorphine cream due to sterility assurance concerns identified during an FDA inspection.
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 and involves a sterile, injectable medication where sterility assurance was compromised, posing a risk of serious infection.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all configurations of compounded BUPRENORPHINE 0.1/0.05 MG/ML CREAM. The product is labeled for intravenous and subcutaneous use only and is sterile, prescription-only medication. The recall was initiated by the recalling firm in response to FDA inspectional findings.
The FDA identified concerns associated with quality control procedures that impacted the assurance of sterility for the affected product. The agency classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recall covers products distributed nationwide in the United States. Affected lots are identified by the codes 04252013@12 and 07232013@25. Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Compounded Injectable
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)
- 04252013@12 and 07232013@25
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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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