The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-979-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Methylprednisolone Acetate Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Methylprednisolone Acetate injectable products because FDA inspectional findings raised concerns about quality control procedures that impacted 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 involves a lack of assurance of sterility in injectable products, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling Methylprednisolone Acetate 40 mg/ml and 80 mg/ml injectable products. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use only. The products were compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, located in Southfield, Michigan.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The distribution pattern for these products was nationwide in the USA.

Consumers and healthcare providers should stop using the recalled products immediately. Patients who have received these injections should contact their healthcare provider for further guidance. The recall is classified as FDA Class II.

The recalled product

Product
METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 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 Steroids
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)

  • 03192013@22
  • 03192013@24
  • 02132013@2

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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