The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0550-2016·Announced 2016-01-06

Clindamycin Injection Bags Recalled for Lack of Sterility Assurance

Walgreens Infusion Services is recalling Clindamycin injection Accuflo bags 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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury or structural defects are rated Severe (4). While no specific injuries are reported in the text, the 'lack of assurance of sterility' for an injectable drug represents a significant risk of adverse health consequences, fitting the Class II criteria for a Severe rating.

Plain-English summary

Walgreens Infusion Services is recalling Clindamycin injection, Accuflo bags, compounded by Option Care 148 in San Antonio, Texas. The recall involves 30 bags of two concentrations: 500 mg/NS 50 mL and 900 mg/NS 100 mL. All lots within their expiration dates are affected.

The recall was initiated due to a lack of assurance of sterility. The product was distributed in Texas. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers in Texas who have these specific Clindamycin injection bags should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Injectable
Hazard
Affected units
30

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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