Beacon Hill Medical Pharmacy Recalls B-12 Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-12 Rejuv 25 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 product, which poses a significant risk of serious injury or hospitalization.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, is recalling B-12 Rejuv 25 mg/mL injectable, all configurations, for intravenous and subcutaneous use. The product was compounded in Southfield, Michigan, and distributed nationwide in the United States.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility. The source text does not specify the number of units affected or report any illnesses or injuries associated with the product.
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
- B-12 REJUV 25 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 (8)
- 01112013@18
- 02112013@8
- 03052013@11
- 04032013@19
- 04122013@34
- 05132013@18
- 06052013@37
- 06212013@14 and 06292013@7
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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