Beacon Hill Medical Pharmacy Recalls Ketorolac Tromethamine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Ketorolac Tromethamine 60 mg/mL injectable because FDA inspectional findings raised concerns about quality control and 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of Ketorolac Tromethamine 60 mg/mL Injectable. The product is intended for intravenous and subcutaneous use only and is compounded by the pharmacy.
The recall was initiated following FDA inspectional findings that resulted in concerns associated with quality control procedures. These findings specifically impacted the assurance of sterility for the product.
The recall covers distribution across the USA nationwide. Patients and healthcare providers who have received this product should contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, 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 — 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)
- 03202013@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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