SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling specific lots of Vancomycin HCl IV bags due to the presence of particulate matter, following 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 corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
SCA Pharmaceuticals is recalling 386 bags of Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only. The product is identified by NDC 70004-0920-59 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 20161228@65 (expiration 02/26/2017) and 20161214@76 (expiration 02/12/2017).
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals or their local FDA office for further instructions. The FDA has classified this as a Class I recall.
The recalled product
- Product
- Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 386
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: 20161228@65
- Exp 02/26/2017
- Lot: 20161214@76
- Exp 02/12/2017
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.
See all 7 products in this recall →Related recalls
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