The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1054-2018·Announced 2018-08-15

Guardian Pharmacy Recalls B-Complex Due to Lack of Sterility Assurance

Guardian Pharmacy Services is recalling B-Complex products in 100 mL bags and vials due to a lack of sterility assurance. The affected units were distributed in Texas.

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 involving a significant hazard such as lack of sterility assurance in a compounded drug is rated as Severe (4).

Plain-English summary

Guardian Pharmacy Services is recalling B-Complex products, which are prescription-only medications packaged in 100 mL bags and 100 mL MDV vials. The recall was initiated because of a lack of sterility assurance in the compounded products.

The affected products were distributed in Texas. The specific lots involved are 58572:42 with a use-by date of 05/29/2018, and 58768:42 with a use-by date of 06/20/2018. The total quantity recalled is 2,600 units.

Consumers and healthcare providers should stop using the affected B-Complex products and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Manufacturer
Guardian Pharmacy Services
Category
Drug — Compounded Drug
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 (1)

  • Lots: a) 58572:42 Use By: 05/29/2018 b) 58768:42 Use By: 06/20/2018

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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