Beacon Hill Medical Pharmacy Recalls Calcium EDTA Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 200 mg/mL injectable products 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks like sterility assurance failures in injectable drugs are categorized as Severe (Score 4), particularly when no explicit 'unlikely to cause adverse health consequences' (Class III) designation is present.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all configurations of Calcium EDTA 200 mg/mL Injectable, sterile, for intravenous and subcutaneous use only. The product was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, Michigan, and distributed nationwide in the United States.
The recall was initiated due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CALCIUM EDTA 200 MG/ML INJECTABLE, 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 — 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)
- 02112013@14 and 04102013@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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