The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-946-2013·Announced 2013-09-18

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.

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 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
Hazard

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.

See all 86 products in this recall →

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