The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-975-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Lipolic Acid Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Lipolic Acid injectable products 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 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.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Lipolic Acid 100 mg/mL and 200 mg/mL injectable products. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use only.

The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures. These findings resulted in a lack of assurance regarding the sterility of the affected products. The agency classified this recall as Class II.

The products were distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected Lipolic Acid injectable products and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
LIPOIC ACID 100 MG/ML and 200 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
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 (3)

  • 06272013@25
  • 04152013@26
  • 06262013@19

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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