The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-958-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Freamine III Alt 8.5% Injectable

Beacon Hill Medical Pharmacy is recalling Freamine III Alt 8.5% Injectable due to sterility assurance concerns identified during an FDA inspection.

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 the hazard involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling all presentations of Freamine III Alt 8.5% Injectable. The product is a sterile, prescription-only injectable compounded for intravenous and subcutaneous use. The recall was initiated following FDA inspectional findings that raised concerns regarding quality control procedures that impacted sterility assurance.

The recall covers products distributed nationwide in the United States. Specific lot numbers and expiration dates are listed in the official recall documentation. The source text does not report any specific illnesses or injuries associated with the use of this product.

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatment options. The recalling firm is responsible for managing the recall and providing further information to affected parties.

The recalled product

Product
FREAMINE III ALT. 8.5% 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
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 (13)

  • 03262013@11
  • 01212013@12
  • 02112013@17
  • 02262013@7
  • 03012013@17
  • 04102013@8
  • 04112013@7
  • 04292013@20
  • 05212013@4
  • 06042013@12
  • 06202013@3
  • 07152013@19
  • 07242013@14

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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