The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0145-2019·Announced 2018-11-07

Pharm D Solutions Recalls Caffeine and Sodium Benzoate Injection Due to Sterility Concerns

Pharm D Solutions is recalling Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL due to a lack of assurance of sterility. The recall covers 567 milliliters 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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product corresponds to a severity score of 4 (Severe), as it implies a risk of adverse health consequences.

Plain-English summary

Pharm D Solutions, LLC is recalling Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable (NDC 69699-1428-02). The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product consists of 567 milliliters. The specific lot number is 07192018:88, with a discard by date of 10/16/2018. The product was distributed nationwide.

Healthcare providers and consumers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund. The U.S. Food and Drug Administration 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.

The recalled product

Product
Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
567

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)

  • Lots: 07192018:88 Discard by: 10/16/2018

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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