The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-983-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Nalbuphine HCL Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Nalbuphine HCL 20 mg/mL injectable because FDA inspections 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Nalbuine HCL 20 mg/mL injectable, all presentations, for intravenous and subcutaneous use only. The product is sterile and prescription-only.

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 recall covers products distributed nationwide in the United States.

Patients and healthcare providers who have received or used this product should contact their healthcare provider or the recalling firm for further instructions. The source text does not specify specific lot numbers or dates in the narrative, though structured data indicates codes such as 03282013@8, 02282013@2, 04012013@22, 05022013@22, and 05012013@38.

The recalled product

Product
NALBUPHINE HCL 20 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 (5)

  • 03282013@8
  • 02282013@2
  • 04012013@22
  • 05022013@22
  • 05012013@38

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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