The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-988-2013·Announced 2013-09-18

FDA Recalls Phosphatidylcholine Injectable Due to Sterility Assurance Concerns

Beacon Hill Medical Pharmacy is recalling Phosphatidylcholine 50 mg/mL Injectable because FDA inspections raised concerns about quality control and sterility assurance.

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 assurance of sterility in an injectable product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Phosphatidylcholine 50 mg/mL Injectable, compounded by Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) in Southfield, Michigan. The recall covers all presentations of the sterile, prescription-only injectable intended for intravenous and subcutaneous use.

The recall was initiated due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance. The source text does not specify the number of affected units, specific lot numbers, or the exact distribution dates, though the distribution pattern is listed as USA nationwide.

Healthcare providers and patients should discontinue use of the recalled product. Consumers and healthcare facilities should contact the recalling firm, Beacon Hill Medical Pharmacy, P.C., for further instructions on returning or disposing of the product.

The recalled product

Product
PHOSPHATIDYLCHOLINE 50 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 Compounded Drug
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 (1)

  • 07082013@26

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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