SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 716 bags of Vancomycin HCl IV solution 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 recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
SCA Pharmaceuticals is recalling 716 bags of Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only. The product is identified by NDC 70004-0923-59 and was distributed nationwide in the United States.
The recall is being conducted due to the presence of particulate matter. This action follows a recent recall by Hospira of vancomycin hydrochloride 10gm vials for the same reason. The affected lots are 20161213@23 (Exp 2/11/2017), 20161214@80 (Exp 2/12/2017), and 20161215@1 (Exp 2/13/2017).
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 716
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 (6)
- Lot: 20161213@23
- Exp 2/11/2017
- Lot: 20161214@80
- Exp 2/12/2017
- Lot: 20161215@1
- Exp 2/13/2017
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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