The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0138-2019·Announced 2018-11-07

Pharm D Solutions Recalls Ascorbic Acid Solution Due to Sterility Concerns

Pharm D Solutions is recalling Ascorbic Acid 500 mg/mL Solution due to a lack of assurance of sterility. The recall affects nationwide distribution.

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 is assigned a score of 4 (Severe), particularly when involving potential health consequences such as sterility issues in pharmaceutical products.

Plain-English summary

Pharm D Solutions, LLC is recalling Ascorbic Acid 500 mg/mL Solution (NDC 69699-1502-50) because of a lack of assurance of sterility. The product is a 10,000 milliliter solution manufactured in Houston, Texas.

The recall covers Lot 04252018:91, which has a discard-by date of 10/21/2018. The 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.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.

The recalled product

Product
Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Pharmaceutical Solution
Hazard
Affected units
10,000

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: 04252018:91 Discard by: 10/21/2018

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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