SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.25 g in 5% Dextrose 250 mL due to the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only. The product is identified by NDC 70004-0922-40, Lot 20161221@70, and an expiration date of 02/04/2017. The recall is due to the presence of particulate matter in the product.
The recall was initiated following a recent recall by Hospira of vancomycin hydrochloride 10gm vials, which was also due to the presence of particulate matter. The affected SCA Pharmaceuticals product was distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 50
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 (2)
- Lot: 20161221@70
- Exp 02/04/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by SCA Pharmaceuticals 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.
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