Beacon Hill Medical Pharmacy Recalls Hydroxocobalamin Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Hydroxocobalamin (Vitamin B12A) 1 mg/mL injectable products due to FDA inspectional findings regarding quality control and 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling Hydroxocobalamin (Vitamin B12A) 1 mg/mL injectable products. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use. The products were compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, 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. These findings specifically impacted the assurance of sterility for the affected products. The agency classification for this recall is Class II.
Patients who have received these products should consult their healthcare providers for guidance. The source text does not specify the number of affected units or report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- HYDROXOCOBALAMIN (VITAMIN B12A) 1 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.
- 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 (5)
- 01042013@16
- 02262013@21
- 03072013@9
- 03042013@23
- 07022013@36 07252013@18
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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