Beacon Hill Medical Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable
Beacon Hill Medical Pharmacy is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable due to sterility assurance concerns identified during an FDA inspection.
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. The hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable. The product is available in all presentations and is intended for intravenous and subcutaneous use only. It is a sterile, prescription-only compounded medication.
The recall was initiated because FDA inspectional findings raised concerns regarding quality control procedures that impacted the assurance of sterility. The source text does not specify the number of units affected, specific lot numbers beyond the provided codes, or the exact distribution dates.
Healthcare providers and patients who have received this product should contact their healthcare provider or the recalling firm for instructions on how to proceed. Consumers should not use the product until further notice.
The recalled product
- Product
- DEXAMETHASONE SODIUM PHOSPHATE 10 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.
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 (3)
- 01162013@13
- 05202013@23
- 07112013@11
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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