Beacon Hill Medical Pharmacy Recalls Cyanocobalamin Injections Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded cyanocobalamin injections because FDA inspections raised concerns about sterility assurance and quality control.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant quality control failures like sterility assurance in injectable products are categorized as Severe.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all presentations of CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, compounded for intravenous and subcutaneous use. The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures impacting sterility assurance.
The affected product is a sterile, prescription-only compounded solution distributed nationwide in the United States. The recall covers specific batches identified by the following codes: 01092013@12, 02132013@17, 03122013@21, 04122013@33, 05132013@17, 05282013@26, 06052013@33, 06252013@4, 06272013@2, and 07152013@41.
Patients who have received this medication should consult their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with the use of these products.
The recalled product
- Product
- CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, 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 — Compounded 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 (9)
- 01092013@12
- 02132013@17
- 03122013@21
- 04122013@33
- 05132013@17 05282013@26
- 06052013@33
- 06252013@4
- 06272013@2
- 07152013@41
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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