The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0188-2019·Announced 2018-11-07

Pharm D Solutions Recalls Sterile Water Bags Due to Sterility Concerns

Pharm D Solutions is recalling 10 bags of Sterile Water 50 mL Aqueous Solution because the company cannot guarantee the product's 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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as lack of sterility in an injectable solution) corresponds to a severity score of 4 (Severe), as it is not Class I but involves significant risk.

Plain-English summary

Pharm D Solutions, LLC is recalling 10 bags of Sterile Water 50 mL Aqueous Solution (NDC 69699-1421-50). The recall was initiated because the company lacks assurance of the product's sterility.

The affected product is identified by Lot 08092018:38 and has a discard-by date of 2/5/2018. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed nationwide. 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
Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Sterile Water
Hazard
Affected units
10

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: 08092018:38 Discard by: 2/5/2018

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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