The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1011-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Zinc Sulfate Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Zinc Sulfate 1 mg/ml 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. According to the rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is categorized as Severe (Score 4), as it poses a significant risk of infection or injury.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling Zinc Sulfate 1 mg/ml Injectable, all configurations, for intravenous and subcutaneous use only. The product is sterile, prescription-only, and was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting sterility assurance. The source text does not specify the number of units affected or the specific dates of distribution, though code information 02082013@9 and 06102013@16 is provided.

The product was distributed nationwide in the USA. Patients and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, 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 (2)

  • 02082013@9
  • 06102013@16

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