The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-998-2013·Announced 2013-09-18

Sodium Bicarbonate Injectable Recalled for Sterility Assurance Concerns

Beacon Hill Medical Pharmacy is recalling Sodium Bicarbonate PF 8.4% Injectable due to FDA inspectional findings regarding 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. Per the rubric, FDA Class II recalls involving significant safety concerns such as sterility assurance in injectable products are categorized as Severe.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling all presentations of Sodium Bicarbonate PF 8.4% Injectable. The product is compounded by the pharmacy, operating as Rxtra Solutions in Southfield, Michigan, and is intended for intravenous and subcutaneous use only.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. These findings specifically impacted the assurance of sterility for the product. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of the recalled product.

The recall is distributed nationwide in the United States. Patients and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
SODIUM BICARBONATE PF 8.4% 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)

  • 03262013@5
  • 01212013@6
  • 01232013@5

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 →

Related recalls

Same manufacturer · Beacon Hill Medical Pharmacy, P.C.

See all →

Same hazard · sterility

See all →

Similar recalls