The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0531-2016·Announced 2016-01-06

Walgreens Recalls L-Cysteine Syringes Due to Sterility Concerns

Walgreens Infusion Services is recalling 14 L-Cysteine 800 mg syringes in Texas because the agency could not ensure the product was sterile.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (lack of sterility assurance) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Walgreens Infusion Services is recalling 14 syringes of L-Cysteine 800 mg (16 mL), prescription only, that were compounded by Option Care 148 in San Antonio, Texas. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product was distributed in Texas. The recall covers all lots within the expiry date. The source text does not specify a particular lot number or expiration date.

Consumers who have this product should contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Compounded Medication
Hazard
Affected units
14

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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