Beacon Hill Medical Pharmacy Recalls Copper Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Copper 0.4mg/mL Injectable due to FDA inspectional findings regarding 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 sterility assurance in an injectable product, which poses a significant risk of infection or injury.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Copper 0.4mg/mL Injectable, all presentations. The product is intended for intravenous and subcutaneous use only and is compounded sterile.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting sterility assurance. The source text does not specify the number of units affected or the specific distribution locations beyond the manufacturer's location.
Consumers and healthcare providers should discontinue use of the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- COPPER 0.4MG/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)
- 04042013@23
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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