The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0176-2019·Announced 2018-11-07

Pharm D Solutions Recalls Pyridoxine Injectable Due to Sterility Concerns

Pharm D Solutions is recalling Pyridoxine 100 mg/mL injectable vials due to a lack of assurance of sterility. The product was distributed nationwide.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility is not assured is categorized as Severe (Score 4) due to the potential for significant injury or infection, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

Pharm D Solutions, LLC is recalling Pyridoxine 100 mg/mL, 30 mL MDV Injectable (NDC 69699-1614-30) because of a lack of assurance of sterility. The recall involves 600 milliliters of the product, specifically Lot 03132018:47, which had a discard-by date of September 9, 2018.

The affected product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the recalled product and contact Pharm D Solutions for further instructions or a replacement. Consumers should not use the product if they have it in their possession.

The recalled product

Product
Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
600

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: 03132018:47 Discard by: 9/9/2018

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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