The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0542-2016·Announced 2016-01-06

Walgreens Recalls Thiamine Syringes Due to Sterility Concerns

Walgreens Infusion Services is recalling 23 Thiamine 100 mg syringes in Texas due to a lack of assurance of 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Walgreens Infusion Services is recalling 23 syringes of Thiamine 100 mg (1 mL), prescription only, which were compounded by Option Care 148 in San Antonio, Texas. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product was distributed in Texas. The recall covers all lots within their expiration dates. No specific lot numbers or dates are provided in the source text.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Injectable
Hazard
Affected units
23

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)

  • All lots within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 33 recalled by Walgreens Infusion 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 33 products in this recall →

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