The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1031-2013·Announced 2013-09-18

Wellness Pharmacy Recalls Magnesium Sulfate Vials Due to Sterility Concerns

Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.

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 microbial contamination of a sterile injectable product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Wellness Pharmacy, Inc. is recalling 590 vials of Magnesium Sulfate Hepta 50% PF, Single Use Vial (2 mL and 10 mL sizes). The affected product is identified by Lot # 130613@38 with a Use By date of 12/10/2013. The product was distributed nationwide and in Puerto Rico.

The recall was initiated due to laboratory results indicating microbial contamination. The FDA expressed concern that test results obtained from the recalling firm's contract testing laboratory may not be reliable, leading to a lack of assurance of sterility for the product lots.

Consumers and healthcare providers should stop using the affected product and contact Wellness Pharmacy at 1-800-227-2627 for further instructions.

The recalled product

Product
Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
Manufacturer
Wellness Pharmacy, Inc.
Category
Drug — Injectable
Hazard
Affected units
590

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)

  • Lot# 130613@38
  • Use By: 12/10/2013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Wellness Pharmacy, Inc. 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 6 products in this recall →

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