The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1053-2018·Announced 2018-08-15

Guardian Pharmacy Recalls Ascorbic Acid TPN Bags Due to Sterility Concerns

Guardian Pharmacy Services is recalling 5,000 bags of Ascorbic Acid 500 mg/mL TPN in Texas due to lack of sterility assurance.

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, and the hazard involves a lack of sterility assurance in a parenteral product, which poses a significant risk of serious injury.

Plain-English summary

Guardian Pharmacy Services is recalling 5,000 bags of Ascorbic Acid 500 mg/mL 500 mL TPN. The product is prescription-only and was distributed in Texas. The recall is being conducted due to a lack of sterility assurance.

The affected lots are 58555:42, 58567:42, 58563:42, 58547:42, and 58565:42, all with a use-by date of 05/25/2018. The product was compounded by Guardian Pharmacy Services, located at 7920 Elmbrook Dr. Ste. 108C, Dallas, TX 75247.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Manufacturer
Guardian Pharmacy Services
Category
Drug — Total Parenteral Nutrition
Hazard

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 (6)

  • Lots: 58555:42
  • 58567:42
  • 58563:42
  • 58547:42
  • 58565:42
  • Use By: 05/25/2018

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 23 recalled by Guardian Pharmacy Services 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 23 products in this recall →

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