Beacon Hill Medical Pharmacy Recalls B-Complex Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-Complex/Lido/B-12 injectable products because FDA inspections 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable product, 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. is recalling B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE products. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use only. The products were compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI, and distributed nationwide in the USA.
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 affected products.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The agency classification for this recall is Class II.
The recalled product
- Product
- B-COMPLEX/LIDO/B-12, 25MG/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@33
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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