The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0167-2019·Announced 2018-11-07

Pharm D Solutions Recalls Magnesium IV Solution Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Magnesium 40 gm/ns 1000 mL IV solution because there is a lack of assurance of sterility.

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, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports, or high-risk scenarios.

Plain-English summary

Pharm D Solutions, LLC is recalling Magnesium 40 gm/ns 1000 mL IV solution (NDC 69699-0904-10). The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product consists of 4 vials per unit. The specific lot number is 05242018:04, with a discard-by date of 8/22/2018. The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be discontinued and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — IV Solution
Hazard
Affected units
4

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 (1)

  • Lot: 05242018:04 Discard by: 8/22/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC 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 79 products in this recall →

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