The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-943-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Calcium Chloride Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Calcium Chloride 100 mg/mL Injectable 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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectables) fall under the Severe category, and the rule states that if the agency's classification is FDA Class I or II, the score should not be below 4 if significant risk is present, though strictly Class II is often 3 or 4. Given the sterility issue in an injectable drug, which carries a high risk of infection (serious injury), a score of 4 is appropriate to reflect the severity of the hazard, aligning with the 'Severe' label for significant injury risks or Class II with high potential for harm.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Calcium Chloride 100 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 lots with the following codes: 02042013@22, 04102013@23, 05072013@18, 05312013@23, and 07242013@3.

The product was distributed nationwide in the United States. Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
CALCIUM CHLORIDE 100 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)

  • 02042013@22
  • 04102013@23
  • 05072013@18
  • 05312013@23
  • 07242013@3

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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