SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 490 bags of Vancomycin HCl IV solution due to the presence of particulate matter, linked to a related Hospira recall.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
SCA Pharmaceuticals is recalling 490 bags of Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only. The product is identified by NDC 70004-0924-59 and is distributed nationwide in the United States.
The recall is being conducted due to the presence of particulate matter in the product. This action follows a recent recall by Hospira of vancomycin hydrochloride 10gm vials for the same reason. The affected lots are 20161212@44 (expiration date 2/10/2017) and 20161230@40 (expiration date 2/28/2017).
Healthcare providers and patients should stop using the recalled product immediately. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 490
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 (4)
- Lot: 20161212@44
- Exp 2/10/2017
- Lot: 20161230@40
- Exp 2/28/2017
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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