The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0153-2019·Announced 2018-11-07

Pharm D Solutions Recalls Glutamine Solution Due to Sterility Concerns

Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical solution, which poses a significant risk of infection or serious injury.

Plain-English summary

Pharm D Solutions, LLC is recalling specific lots of Glutamine 10 mg/mL Solution (NDC 69699-1439-59) due to a lack of assurance of sterility. The affected product is a 1095 milliliter solution manufactured in Houston, Texas.

The recall includes lots 01402018:93, 07122018:16, and 08302018:65. The distribution pattern for these products is nationwide. The source text does not specify the exact discard-by date for lot 08302018:65, though dates are provided for the other two lots.

Consumers and healthcare providers should stop using the affected lots and contact Pharm D Solutions, LLC for further instructions or a refund. No illnesses or injuries are reported in the source text.

The recalled product

Product
Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Solution
Hazard
Affected units
1,095

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 (3)

  • Lots: 01402018:93 Discard by: 10/10/2018
  • 07122018:16 Discard by: 9/10/2018
  • 08302018:65 Discard by:

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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