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.
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 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
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.
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