The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0543-2016·Announced 2016-01-06

Walgreens Recalls Folic Acid Syringes Due to Sterility Concerns

Walgreens Infusion Services is recalling 23 folic acid syringes compounded 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Walgreens Infusion Services is recalling 23 syringes of Folic Acid 1 mg/0.2 mL, prescription only. The product was compounded by Option Care 148 in San Antonio, Texas, and distributed within Texas. The recall was initiated because of a lack of assurance of sterility.

The affected product consists of 23 syringes, and all lots within the expiry date are included in the recall. No specific lot numbers or expiration 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 return or disposal.

The recalled product

Product
Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
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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